By Alexander Gaffney

A bipartisan bill introduced in the House of Representatives would work to speed up the development and review of some drugs intended to treat life-threatening diseases by creating a new “breakthrough therapy” designation at the US Food and Drug Administration (FDA).

The bill, To amend chapter V of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to expedite the development and review of breakthrough therapies, would amend the FD&C Act to include provisions to allow a sponsor to request the breakthrough therapy designation for a drug after the sponsor submits an investigational new drug application (INDA) for that product.

A sponsor’s request would be accepted if the drug, either by itself or in combination with other medicines, is intended “to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.”

FDA would then have 60 days to make a decision regarding the sponsor’s request. Upon designating a product as a breakthrough therapy, the agency could then expedite the review process in several ways including holding additional meetings with the sponsor, provide advice and communications to the sponsor, provide a cross-disciplinary review team for the product and take steps to ensure the product’s clinical trial design is “as efficient as practicable.”

The bill is co-sponsored by Reps. Brian Bilbray (R-CA) and Diana DeGette (D-CO) and has been referred to the House Committee on Energy and Commerce for review and markup.

Read more:

H.R.5334 — To amend chapter V of the Federal Food, Drug, and Cosmetic Act to expedite the development and review of breakthrough therapies. (Introduced in House – IH)

Pretreatment serum samples from 114 patients treated with bevacizumab plus erlotinib were classified as either VeriStrat Good or VeriStrat Poor.  The study showed there was a statistically significant difference in overall survival between the two groups.  Patients classified as VeriStrat Good had a median overall survival of 13.4 months versus 6.2 months for patients classified as VeriStrat Poor (p=0.0027, HR=0.480, 95%CI:0.294-0.784).  Median progression free survival for patients classified as VeriStrat Good was 4.0 months and 3.2 month for patients classified as VeriStrat Poor, but this difference was not statistically significant (p=0.2632, HR=0.768, 95% CI: 0.482-1.223).

Researchers concluded that the VeriStrat test may be useful for clinical decision-making, representing a prognostic and potentially predictive biomarker for treatment with erlotinib and erlotinib combinations.  Prospective trials are ongoing, including a Phase III trial in advanced squamous cell lung cancer, sponsored by the European Thoracic Oncology Platform (ETOP).

“These data represent the third study in which we have shown that VeriStrat classification correlates with survival outcomes in lung cancer patients treated with bevacizumab plus erlotinib,”commented David Brunel, CEO of Biodesix. “Although additional data is needed, this study supports the view that VeriStrat may be useful in identifying lung cancer patients that could benefit from the combination of bevacizumab and erlotinib, which is regarded as less toxic than traditional chemotherapy.”

About VeriStrat:  VeriStrat is a serum proteomic test currently available for patients with advanced NSCLC.  The test identifies patients who are likely to have good or poor outcomes after treatment with epidermal growth factor receptor inhibitors (EGFRIs).  Samples are processed in Biodesix’ CLIA certified laboratory and results are typically reported within 72 hours of sample shipment.  VeriStrat has been validated in clinical studies with over 1500 patients.  For more information on VeriStrat or to order VeriStrat, visit www.VeriStratSupport.com or call the VeriStrat Support Hotline at 1-866-432-5930.

About Biodesix:  Biodesix is a personalized medicine company focused on the development of diagnostic products that inform treatment decisions and improve patient care.  The Company’s goal is to give physicians more information about the patient and their disease; understanding the clinically meaningful information contained within each patient’s molecular profile leads to better care and better outcomes. The Company’s unique approach is based on ProTS®, proprietary technology which exploits the power of mass spectrometry and enables the discovery of specific molecular profiles. Biodesix collaborates with clinical investigators to address critical clinical questions, and partners with biotechnology and pharmaceutical companies to develop diagnostics to select patients most likely to benefit from novel therapies. For more information about Biodesix, please visit www.Biodesix.com.

This press release contains statements that are hereby identified as “forward-looking statements” for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the Company’s inability to further identify, develop and achieve commercial success for products and technologies; the risk that the Company’s financial resources will be insufficient to meet the Company’s business objectives; uncertainties relating to the regulatory approval process and changes in relationships with strategic partners. We disclaim any intent or obligation to update these forward-looking statements.

The Fiscal Year 2012 (FY12) Defense Appropriations Act provides $10.2 Million (M) to the Department of Defense Lung Cancer Research Program’s (LCRP) to support innovative, high-impact lung cancer research.  The LCRP is administered by the US Army Medical Research and Materiel Command (USAMRMC) through the Office of the Congressionally Directed Medical Research Programs (CDMRP).

http://cdmrp.army.mil/funding/lcrp.shtml

Concept Award will be released at a later time.  Deadlines for the Concept award are not known at this time.

Idea Development Award – preapplication due May 30, 2012
Independent investigators at or above the level of an Assistance Professor (or equivalent); must be within 10 years of first faculty appointment.
Supports new ideas that are in the early stages of development which represent innovative, high-risk/high-gain research that could lead to critical discoveries or major advances that will accelerate progress toward eradicating deaths from lung cancer.
Emphasis is on Innovation and Impact.
Preliminary data required, but may be from outside of lung cancer.
Clinical trials are not allowed.
Maximum funding of $350K for direct costs (plus indirect costs).
Maximum period of performance is 2 years.

Translational Research Partnership Award – preapplication due May 30, 2012
Investigators at or above the level of Assistant Professor (or equivalent).
Partnership: One investigator must be a laboratory scientist, and the other must be a clinician.
Supports partnership[s between clinicians and laboratory scientists that accelerate the movement of promising ideas in lung cancer into clinical applications.
Preliminary data required, but may be from outside of lung cancer.
Clinical trials are not allowed.
Optional Nested Clinical Fellow or Resident Traineeship.
Maximum combined funding of $900K for direct costs (plus indirect costs).
Maximum period of performance is 3 years.
Nested traineeships:  Additional maximum of $75K in direct and indirect costs over a one-year period of performance.

All applications must conform to the Program Announcements and application instructions available for electronic downloading from the Grants.gov website.  The application package containing the required forms for each award mechanism will also be found on Grants.gov. A listing of all USAMRMC funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420.

A pre-application is required and must be submitted through the CDMRP eReceipt website (http://cdmrp.org) prior to the pre-application deadline of May 30, 2012.  Applications must be submitted through the federal government’s single-entry portal, Grants.gov .

Requests for email notification of the Program Announcements release may be sent tohelp@cdmrp.org .

For more information about the LCRP or other CDMRP-sponsored programs, please visit theCDMRP website (http://cdmrp.army.mil ).

Point of Contact:

CDMRP helpdesk
301-682-5507
help@cdmrp.org

The story was about Chris Draft losing his wife to lung cancer just five weeks after they got married. She had been diagnosed with stage IV cancer just 8 months before he proposed. “You can’t guarantee what’s tomorrow,” he said. “If it’s one more day, I’ll take it. Two? I’ll take that. But to have that with your wife, the woman that you love? I’ll take seconds.” We were all swept away. Here’s the video of the segment in its entirety.

Chris Draft – Love and Loss

This is very personal to me because my own mom died from lung cancer in 2007. And just like Lakeasha, my mom had never smoked and was in the prime of her life. This strange fact is a growing reality about the disease that the lung cancer community is working tirelessly to raise awareness about. Chris and Keasha started the Team Draft Foundation and one its mission objectives is to do just that: change the face of lung cancer.

Non-smokers are a growing portion of those who are diagnosed, 80% to be exact. And the numbers paint a story that I feel everyone should know. Over 160,000 people will die from lung cancer in the U.S., that is more than many other cancers combined, including cancers in the breast, colon and brain.  Despite being the leading cancer killer in America, research funding is disproportionately spread out. For every lung cancer death, approximately $1,400 was spent in research compared to the nearly $24,000 spend for every breast cancer death in 2011. As a result, survival rates naturally have stagnated — up only two percent since the 1970s to 15%.

A big part of this is the awareness issue. Letting go of the “smokers get cancer” stigma. I’m inspired by Chris Draft and the Foundation’s aim to fight for more research and awareness. I hope that the Foundation will work to empower young adults to take up this issue, as that is a critical step in tomorrow’s fight against the disease. I have admittedly been discouraged from continuing to advocate for the very cancer that took my mom’s life. I often find myself being the youngest person in the room at conferences and meetings…it’s kind of a buzz kill. And the support for young adults involved in the lung cancer fight is sparse. A lot is on my mind tonight as I envision Gen-Y talking more about our generation’s biggest threat next to heart disease.

Just a few thoughts:

STORIES MATTER – We need to actively shed light on more of these stories. As tragic as they are, they provide an undeniable truth that young people are suffering from this disease. Two years ago, there was some traction when 21 year old Cal student Jill Costello passed away from the disease and our community rallied behind her. We need to swing into the light and tell our story.

THINK POSITIVE – Many of the campaigns I have seen to raise awareness have been fact driven, just as my quick blurb above gave statistics on the current situation. But much of this kind of awareness strategy had understandably taken the angry road in delivering message. The lung cancer community needs a positive light to its vibe. Something people can rally behind rather than droop their heads as they talk about it.  We can compare our funding and survival rates with other cancers, but we shouldn’t bash on their success at raising awareness. It was a turn off for me when a group of lung cancer advocates I was at a conference with started throwing down some hate on the breast cancer movement because of the traction they got in their pink ribbon campaign. It turned me off. Make our own story something people can get behind. Make it positive, give it some hope.

GENERATION Y – Gen-Y has been able to do some remarkable things. Many of us are in our mid 20s and 30s and we’ve been able to start businesses and movements, petitions and protests. Our excitement and passion, when kindled, is undeniable. We have figured out ways to make profit while changing the world all in the same transaction. We have done wonders with social media. We have changed the outcomes of your normal voting pattern. But there is a caveat to all of this madness. All of what we’ve been able to do has been because we’ve been inspired, engaged and challenged. Call us entitled, but yes, in other words — we need to feel like we matter. Win the hearts of generation Y — and the lung cancer cause will be advanced, and won, like no other.

The story of Chris Draft has inspired me to once again light the fire inside of me that is forever a part of my life story. It’s a fight that I’m most certainly proud of, despite how devastating it has been to those it has affected. Lung cancer is a demon.  But this story has given me new hope.

I was never into football, but now I can say I have a favorite player. A new role model, and possibly someone I can meet someday to join hands in this fight we share together. Props and prayers, Chris.

Lung cancer advocates, what do you think can improve our engagement of our communities in the discussions about lung cancer? I’m really interested to hearing what you all think.

More than a quarter century after Yul Brynner’s death from lung cancer, treatment advances offer some patients new options, but the cancer continues to claim more lives than any other. And the actor’s haunting anti-smoking message lives on.

When Richard Rodgers and Oscar Hammerstein’s musical The King and I opened on Broadway on March 29, 1951, expectations were high. The famed songwriting team had already created four hit shows, and the role of Anna was to be played by theater star Gertrude Lawrence, whose name blazed across the top of the marquee. Less attention was paid to the relatively unknown actor Yul Brynner, who had been cast as the King. But after opening night, no one would forget his name.

An International Upbringing

Yul Brynner was born Juli Borisovitch Bryner, in Vladivostok, Russia, on July 11, 1920, the second child of Boris Bryner and Marousia Blagovidova. (He added the second “n” to his last name years later, so that English speakers would pronounce it properly.) Vladivostok is a port city located in the southeastern region of Russia, close to the Sea of Japan. As Yul Brynner’s son, Rock, explains in his book Empire & Odyssey: The Brynners in Far East Russia and Beyond, for three generations the family’s choices were closely intertwined with the city’s location and the wars that encompassed the region.

Yul Brynner’s grandfather Julius Bryner moved from Switzerland to Vladivostok in the 1870s, established a successful import-export company, and went on to become one of the city’s most respected businessmen. Boris Bryner followed in his father’s footsteps; when Vladivostok became part of the newly established (and short-lived) Far Eastern Republic in 1920, during the Russian Civil War, he was asked to serve as minister of industry.

Boris Bryner’s high-powered position required extensive travel, and when Yul was 3, his father left his mother for a woman he had met in Moscow. To escape ongoing regional conflict, Yul’s mother moved him and his older sister to Harbin, China. But as war loomed between China and Japan, she feared a Japanese invasion of Harbin, and in 1932 she moved the family to France. There, Yul’s dreams of becoming an actor blossomed as he played guitar in Russian nightclubs in Paris, trained as a trapeze acrobat and joined a theater company. But Paris was not home for long. In 1938, Yul’s mother was diagnosed with leukemia, and, fearing that the Germans would soon invade France, she and Yul moved back to Harbin. By 1940, it became clear that he could no longer care for his mother alone, and the two moved to New York City, where his sister lived.

The Lights of Broadway
When he arrived in New York, Brynner barely spoke English. But that didn’t stop him from heading off to Connecticut to study acting with the renowned Russian teacher Michael Chekhov. There, he learned how to use his voice and body and began to embrace what it meant to be an actor. “When you are a pianist,” Brynner later explained, “you have an outside instrument that you learn to master through finger work and arduous exercises. … As an actor, you the artist have to perform on the most difficult instrument to master, that is, your own self—your physical and your emotional being.”

Brynner’s first Broadway performance was a small part in Shakespeare’s Twelfth Night in December 1941. Over the next few years, his acting opportunities were few, and Brynner decided to follow his first wife, actress Virginia Gilmore, to Hollywood, where he found work as a director at the new television station CBS. His path seemed set. Then in 1950 a friend convinced him to return to New York City to audition for the King.

​
Yul Brynner possessed a commanding presence both onstage and beyond (in London in 1978.)​ | Photo © Hulton-Deutsch Collection / Corbis

Virtually overnight, Brynner became a household name. In 1952, he won a Tony Award for his performance in The King and I, and when the play was made into a movie a few years later, there was no question the part was his. Brynner proved to be as good on film as he was onstage, winning the 1956 Academy Award for Best Actor. Over the next two decades, Brynner appeared in more than 40 other films, but it was the role of the King that he returned to time and time again.

A Cancer Diagnosis
In September 1983, Brynner made an appointment to see his physician after finding a lump on his vocal chords. (He had been diagnosed with a precancerous lump on his larynx just the year before.) Brynner was in Los Angeles, with only three hours to go before he took the stage for his 4,000th performance, when he received the test results. The new lump was merely an enlarged gland, he learned. But there was a much bigger problem: He had lung cancer, and the tumor was too close to his heart to attempt surgery.

Initially, Brynner was determined to keep performing. But ultimately he had to admit that the radiation therapy, which was his only option for treatment, had made his throat so painful he could no longer act. It also became clear that the public wasn’t eager to watch an esteemed actor struggling with the effect cancer was having on his performance. “He called me one day to tell me ticket sales were falling off,” says Rock. “ ‘Cancer,’ he complained, ‘is a real poison at the box office.’ ”

Lung Cancer’s Toll

When Brynner was diagnosed, lung cancer was the leading cause of cancer deaths among American men, and the second-leading cause of cancer deaths among American women. It is now the leader among both men and women, with more Americans dying of it than of colon, breast and prostate cancer combined. The American Cancer Society estimated that in 2011 about 221,000 Americans would be diagnosed with lung cancer, and that about 157,000 would die of it, making the disease responsible for about 27 percent of all U.S. cancer deaths this year.

Yet many people remain unaware of lung cancer’s toll. A recent survey of 1,000 Americans conducted by the National Lung Cancer Partnership, a nonprofit patient support organization, found that nearly 80 percent of the respondents didn’t know that the No. 1 cancer killer in the U.S. is lung cancer. This is due, in part, to the fact that there are few long-term survivors. “Because lung cancer has a [five-year] survival rate of only 15 percent, you don’t have that mass of survivors who want to stand up and give back and say thank you for saving my life,” says Kim Norris, the president of the Los Angeles–based Lung Cancer Foundation of America. The lack of public awareness is also connected to the smoking-related stigma attached to lung cancer, she says. “Even family members can become victims of the stigma and be hesitant or unwilling to become an advocate or donate to an advocacy organization,” says Norris, “because they believe their loved one did this to themselves.”

The stigma attached to lung cancer also affects both government funding and corporate donations. Regina Vidaver, the executive director of the National Lung Cancer Partnership, explains that if you look at cancer funding through the lens of each cancer’s contribution to cancer deaths, lung cancer receives a disproportionately small share of the funding pie. In 2009, the National Cancer Institute’s research budget allotted just under $247 million for lung cancer, compared with $294 million for prostate cancer, and about $600 million for breast cancer.

Treatment Advances
Despite this funding disparity, lung cancer treatments have advanced in important ways since Brynner’s death in 1985. If Brynner had been diagnosed today, says Daniel Morgensztern, a clinical oncologist at the Yale Cancer Center in New Haven, Conn., “I think his odds might have been better.” Improved surgical techniques, he says, might have made it possible for Brynner to have surgery, despite the tumor’s proximity to his heart. He’d also have had a PET scan (a technology that wasn’t widely available until 1998) to see if the tumor had spread to other organs. This would have helped to determine his treatment.

Brynner also would have been offered more treatment options. The type and stage of Brynner’s lung cancer are unknown, but it’s likely he had non–small cell lung cancer. If he was stage III, says Morgensztern, he’d probably have had chemotherapy in addition to radiation. If he was stage IV, his tumor would have been tested to see if he was a candidate for one of the targeted therapies that in the early 2000s began to be approved for the treatment of advanced non–small cell lung cancer.

One of these drugs is bevacizumab (Avastin), which can disrupt angiogenesis—the growth of the blood vessels a tumor needs to survive—by blocking a protein called vascular endothelial growth factor (VEGF). Others are therapies known as epidermal growth factor receptor (EGFR) inhibitors, which work by blocking a protein that fuels tumor growth. These drugs—erlotinib (Tarceva), gefitinib (Iressa) and cetuximab (Erbitux)—are effective in only lung tumors that test positive for the EGFR genetic mutation. The most recent targeted therapy option is crizotinib (Xalkori), a drug that inhibits a biochemical pathway called anaplastic lymphoma kinase (ALK), which promotes tumor growth. It received approval from the U.S. Food and Drug Administration in August 2011 for the treatment of advanced non–small cell lung cancer that has an altered ALK gene. Studies suggest that about 3 to 5 percent of non–small cell lung cancers have this alteration.

Yul Brynner starred in more than 40 movies, including the 1956 film The Ten Commandments. But shortly before his death, the public wasn’t eager to watch him struggle with the effect cancer was having on his performances.​ | Photo © Cinemaphoto / Corbis

A Dramatic Ending
Brynner was well aware that although he’d quit smoking in 1971, he was still at risk of developing lung cancer, says Rock. He’d smoked two-to-four packs a day since the age of 12, and “he was always holding a cigarette in the photos he chose for his publicists to distribute to his fans.”

In an effort to educate others about the risks of tobacco, Brynner orchestrated the creation of an anti-smoking commercial a few months before his death. He arranged an interview on Good Morning America, and he made a point to emphasize the importance of not smoking. Then, working with the American Cancer Society, he used a clip from his interview to create a public service announcement. Within days of his death, the PSA was running on the three major U.S. television networks, as well as on other stations throughout the world. For 30 seconds, his brown eyes stared into the camera, his distinctive voice uttering one last haunting plea: “Now that I’m gone, I tell you: Don’t smoke. Whatever you do, just don’t smoke.”

The idea that Brynner would have orchestrated a commercial that would influence how he was perceived decades later didn’t surprise anyone who knew him well. “He was the Emperor of the Universe,” says Rock. “Not just the King or the Pharaoh. He controlled everything within earshot and beyond. … From age 12 he learned how to seize control of every eyeball in a room.”

Despite guidelines calling for genetic mutation testing in certain patients with lung cancer, three new surveys fielded by Harris Interactive reveal a disconnect in the understanding of and communication about genetic mutation testing among healthcare professionals and cancer patients. Results of the surveys were announced today by Boehringer Ingelheim Pharmaceuticals, Inc., which sponsored the surveys in partnership with the Association of Community Cancer Centers (ACCC), ONS:Edge and the National Lung Cancer Partnership (NLCP).

Surveys of 95 community oncologists, 522 oncology nurses and 436 lung cancer patients across the U.S. were collected in October 2011 to measure perceptions and knowledge of genetic mutation testing and to identify unmet needs and gaps in education.

Cancer researchers are increasing their understanding of how certain mutations to cell DNA can cause cells to grow abnormally and form cancers, including lung cancer. Genetic mutation testing has the potential to identify these mutations and can aid in informed treatment decisions, but since the field is relatively new, knowledge of genetic mutation testing remains low and the practice has not been widely adopted.

The surveys found that while 94 percent of physicians responded that they discuss genetic mutation testing with their patients, only 17 percent of lung cancer patients surveyed were aware of genetic mutation testing. Nearly half of oncology nurses (44 percent) did not discuss genetic mutation testing with patients, primarily because they felt that they lacked the knowledge to discuss it (56 percent) or didn’t have the proper resources to share with their patients (33 percent). These findings highlight the need for a greater understanding of genetic mutation testing.

“Boehringer Ingelheim is committed to exploring the potential of personalized medicine and is excited by the possibility of being able to tailor an individual patient’s treatment based on genetic information,” said Christopher Corsico, M.D., M.P.H., Sr. Vice President, Medicine and Regulatory, Boehringer Ingelheim Pharmaceuticals, Inc. “Knowledge of genetic mutation testing among the medical and patient communities will help ensure that patients are receiving the most appropriate care as early as possible.”

Community Oncologists Focused on Testing, Face Barriers

The vast majority of community oncologists surveyed responded that they discuss genetic mutation testing with their peers during tumor boards (88 percent) and with their cancer patients (94 percent), and that patient discussions were driven by their desire for patients to be informed about all aspects of their treatment (89 percent) and for patients to have access to personalized therapies (78 percent). Despite this, respondents identified a number of issues related to testing, including cost, concerns regarding tissue acquisition and delays in initiating treatment.

“Community oncologists treat an estimated 60 percent of cancer patients nationwide, but as these results show, cost challenges, likely related to reimbursement, as well as issues including lack of tissue and multiple labs involved in testing create structural barriers to use of genetic mutation testing and establishing a treatment plan based on those results,” said Christian G. Downs, JD, MHA, Executive Director, Association of Community Cancer Centers, the leading education and advocacy organization for the cancer team.

Oncology Nurses Lack Resources for Patients

About half of the oncology nurses surveyed discuss genetic mutation testing (56 percent) and personalized medicine (46 percent) with their patients; 59 percent of their patients were very receptive or receptive to testing. However, because the nurses felt that they lacked the knowledge to discuss genetic mutation testing or didn’t have the proper resources, 69 percent were somewhat or not at all comfortable with having this discussion with patients. These findings point to a need for a greater understanding of genetic mutation testing among nurses, including latest practices, particularly because 52 percent of oncology nurses are involved in ordering or obtaining tests or results and they play a major role in helping cancer patients navigate their way through diagnosis and treatment.

“Oncology nurses are pivotal in educating patients about test results and treatment options,” said Keightley Amen, BA, AMWA, Project Manager, ONS:Edge, a subsidiary of the Oncology Nursing Society. “But as these survey results show, nurses need deeper knowledge and better tools to communicate effectively with cancer patients about this relatively new concept in their care.”

Lung Cancer Patients Need Education

Despite the development of personalized therapies that specifically address genetic mutations in lung cancer, only 8 to 10 percent of lung cancer patients surveyed were aware of each of the three primary mutations: epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) and KRAS. Just 16 percent of lung cancer patients surveyed reported that their healthcare professionals discussed genetic mutation testing with them. Only 12 percent indicated that they had a tumor tested for a genetic mutation, with just 10 percent saying that they had requested a genetic mutation test for their lung cancer.

“Approaches to cancer treatment are changing rapidly, and it is important for patients to be educated and feel empowered when interacting with their healthcare team,” said Regina Vidaver, Ph.D., Executive Director, National Lung Cancer Partnership, an advocacy organization dedicated to raising public awareness of the disease and generating funding for lung cancer research. “The more patients, physicians and nurses know about genetic mutation testing, the easier it will be to properly diagnose and establish a treatment plan for the patient.”

About Lung Cancer

Lung cancer is the second most common cancer and kills more people than any other cancer. In 2011, approximately 221,130 new cases of lung cancer will be diagnosed in the United States, with 156,940 Americans dying from the disease. Non-small cell lung cancer (NSCLC) is the most common form, accounting for about 85 percent of all lung cancers.(i) Lung cancer remains an area of high unmet need, especially in its advanced stages where it is particularly aggressive and patients have limited treatment options.

While there are a wide variety of genetic mutations that can lead to lung cancer, the three most common mutations seen in lung cancer are: anaplastic lymphoma kinase (ALK) mutation, which occurs in 5 percent of lung cancer patients; epidermal growth factor receptor (EGFR)-mutation, which occurs in 40 percent of Asians and 10-15 percent of Caucasians with lung cancer; and KRAS mutation, which occurs in 10 percent of Asians and 30 percent of Caucasians with lung cancer.(ii)

About the Association of Community Cancer Centers (ACCC)

Since 1974, the Association of Community Cancer Centers (ACCC) has served as the leading national multidisciplinary organization that sets the standard for quality care for patients with cancer. ACCC is dedicated to promoting professional learning opportunities and to providing a forum for members to network and enhance their skills in the business, clinical and management aspects of care for the cancer community. Nearly 17,000 cancer care professionals from approximately 900 hospitals and more than 1,200 private practices are affiliated with ACCC. The organization’s unique membership includes all members of the cancer care team: medical and radiation oncologists, surgeons, cancer program administrators and medical directors, pharmacists, oncology nurses, oncology social workers, and cancer program data managers. For more information, visit ACCC’s website at www.accc-cancer.org .

About ONS:Edge

ONS:Edge, a subsidiary of the Oncology Nursing Society, is a healthcare intelligence company formed with the explicit purpose of bringing nursing knowledge and research deeper into the business of healthcare. ONS:Edge specializes in a core group of services: healthcare advisory boards, ancillary events at oncology nursing conferences, speaker bureau programs, strategic planning and marketing support, market research, and communications and awareness campaign development and support.

As the for-profit subsidiary of the Oncology Nursing Society (ONS), ONS:Edge’s competitive advantage is unparalleled access to key opinion leaders and the more than 37,000 members of ONS, whose commitment to evidence-based practice and dedication to excellence in patient care put them at the forefront of leading change in oncology care.

About the National Lung Cancer Partnership (NLCP)

The National Lung Cancer Partnership is a 501(c)(3) non-profit organization made up of leading doctors, researchers, patient advocates and lung cancer survivors dedicated to raising public awareness of the disease and generating funding for lung cancer research. For more information please visit www.NationalLungCancerPartnership.org .

About Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 42,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability, are intrinsic factors in all of Boehringer Ingelheim’s endeavors.

In 2010, Boehringer Ingelheim posted net sales of approximately $16.7 billion (about 12.6 billion euro) while spending almost 24 percent of net sales in its largest business segment, Prescription Medicines, on research and development.

For more information, please visit http://us.boehringer-ingelheim.com and follow us on Twitter at http://twitter.com/boehringerus .

References

(i) American Cancer Society. Cancer Facts and Figures: 2011. Available at: http://www.cancer.org/acs/groups/content/ @epidemiologysurveilance/documents/document/acspc-029771.pdf. Last accessed October 13, 2011.

(ii) Quest Diagnostics. Lung Cancer Mutation Panel (EGFR, KRAS, ALK). Available at: http://questdiagnostics.com/hcp/intguide/jsp/showintguidepage.jsp?fn=Lung/TS_LungCancerMutation_Panel.htm . Last accessed October 13, 2011.

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.

Copyright (C) 2011 PR Newswire. All rights reserved

People with Lung Cancer Invited to Submit Their Personal Stories

Kathryn Joosten, two-time Emmy(R) Award-winning actress and star of Desperate Housewives and The West Wing, is opening up about her 10-year battle with lung cancer as part of a new national campaign, Lung Cancer Profiles. Lung Cancer Profiles aims to reduce the stigma associated with lung cancer by educating about the diversity of the disease inside and out. The campaign, created by Pfizer Oncology in collaboration with the nation’s leading lung cancer advocacy groups, also seeks to educate about the role of molecular testing and its potential to uncover the unique genetic drivers of each person’s cancer, which can help doctors devise an individualized treatment plan rather than using a one-size-fits all approach.

“I have lung cancer and it’s nothing to hide–anyone can get lung cancer, everyone’s cancer is different and it’s reassuring that the science is catching on,” Ms. Joosten said. “When my cancer returned after eight years, I was discouraged, but my doctor recommended I get my tumor tested to see if it would affect my treatment plan. We were able to identify my particular type of lung cancer and find a clinical trial designed specifically for people with my tumor type. I am passionate about this campaign because I know, first-hand, how hard it can be to learn you have lung cancer, how important it is to get tested and how impactful sharing my story might be on the lives of others with lung cancer.”

Lung cancer is the number one cause of cancer death worldwide(1) and the leading cause of cancer-related death in women in the United States.(2) Lung cancer can affect anyone: people with and without a history of smoking; young and old; men and women; and people of different ethnicities.(3,4)We now know that, rather than being one singular disease as previously thought, it is made up of many distinct sub-types based on the genetic characteristics of each tumor.(5)

As part of the campaign, in addition to featuring Ms. Joosten’s remarkable story, LungCancerProfiles.com will showcase other patients’ inspiring stories about their journey living with lung cancer. People with lung cancer are encouraged to submit their own personal “profiles” to show the diversity of lung cancer, highlight how molecular testing impacted their lives and provide a small snapshot of the hundreds of thousands of people with this disease.

“Today, we understand that lung cancer is actually made up of many distinct sub-types based on molecular profiling of genetic changes in each patient’s cancer,” said David R. Gandara, MD, professor of hematology and oncology and director of thoracic oncology at University of California Davis Cancer Center. “More and more, this information is changing how oncologists make treatment decisions for their patients. In 2011, we already have the ability to truly individualize therapy for some patients based on this ‘molecular fingerprint,’ and new discoveries are being made at a rapid rate. For now, the take home message is, `If you have lung cancer and your tumor has not already been tested, talk to your doctor to see if molecular analysis is appropriate for you.’”

Lung Cancer Profiles is a collaboration between Pfizer Oncology and the nation’s leading lung cancer patient advocacy organizations: Bonnie J. Addario Lung Cancer Foundation, Lung Cancer Alliance, Lung Cancer Foundation of America, LUNGevity, the National Lung Cancer Partnership and Uniting Against Lung Cancer. The partnership underscores the significant need to support lung cancer patients by educating them about all aspects of lung cancer, including the impact molecular testing potentially can have on diagnosis and treatment.

“For a patient likely overwhelmed with a devastating diagnosis, lung cancer can be a daunting topic to understand,” said Regina Vidaver, PhD, executive director of the National Lung Cancer Partnership. “With our partners, we aim to help patients understand the importance of molecular testing and encourage them to talk to their doctor to learn more. We’re also inviting others to submit their personal ‘profiles’ on the campaign website, to reinforce that lung cancer can impact anyone.”

For more information about Lung Cancer Profiles and to learn about submitting patient stories, visit www.lungcancerprofiles.com .

“Pfizer Oncology is proud to be working with our advocacy partners on this campaign,” said Mace Rothenberg, MD, senior vice president of clinical development and medical affairs for Pfizer’s Oncology Business Unit. “As more therapeutic options become available, we hope that this campaign will help spread the word about the important role of molecular testing in the selection of appropriate treatment for some individuals diagnosed with lung cancer.”

About Lung Cancer

Lung cancer is the leading cause of cancer death in the U.S.,(1) and more people die of the disease than of colon, breast and prostate cancers combined.(1,6)An estimated 221,130 new cases of lung cancer are expected to be diagnosed in the U.S. in 2011, and an estimated 156,940 deaths, accounting for about 27 percent of all cancer deaths, are expected to occur.(7)

Bonnie J. Addario Lung Cancer Foundation ( www.lungcancerfoundation.org )

Bonnie J. Addario Lung Cancer Foundation (BJALCF) has grown into the first international collaborative entity of its kind, raising over $6 million for lung cancer research. BJALCF plans to become the global leader for lung cancer. The ultimate goal of the organization is to increase the low survival rate of lung cancer by becoming the largest source of non-profit funding dedicated to turning Lung Cancer into a manageable chronic disease.

Lung Cancer Alliance ( www.lungcanceralliance.org )

Lung Cancer Alliance is the only national non-profit organization devoted solely to support and advocacy for all those living with or at risk for lung cancer. Headquartered in Washington, DC, Lung Cancer Alliance is organizing state chapters nationwide.

Lung Cancer Foundation of America (LCFAmerica.org)

The Lung Cancer Foundation of America’s mission is to save lives by dramatically increasing the five-year survival rates for all stages of lung cancer, the nation’s leading cause of cancer deaths for both men and women. The LCFA will accomplish this by providing the necessary and critical funding for creative and leading edge lung cancer research programs.

LUNGevity ( www.lungevity.org )

LUNGevity moves forward firmly resolved to provide the energy, inspiration, and resources that are critical to making lung cancer a national priority. Our goal is to Stop Lung Cancer Now. Our vision is a world where no one dies of lung cancer. A world that LUNGevity helped to create by bringing together world-class scientific minds, passionate advocates, and an efficient and effective organization. Our vision is to unite the country in one movement to end lung cancer now.

National Lung Cancer Partnership ( www.nationallungcancerpartnership.org )

The National Lung Cancer Partnership is the only lung cancer advocacy organization founded by doctors and researchers working together with survivors and advocates to increase lung cancer awareness and research funding. Headquartered in Madison, WI, the Partnership supports a nationwide network of grassroots lung cancer advocates through its programs.

Uniting Against Lung Cancer ( www.unitingagainstlungcancer.org )

Uniting Against Lung Cancer funds innovative lung cancer research to find a cure for the nation’s leading cancer killer. We also work to increase awareness of the disease, including in people who have never smoked.

About Pfizer Oncology

Pfizer Oncology is committed to the discovery, investigation and development of innovative treatment options to improve the outlook for cancer patients worldwide. Our strong pipeline, one of the most robust in the industry, is studied with precise focus on identifying and translating the best scientific breakthroughs into clinical application for patients across a wide range of cancers. Pfizer Oncology has biologics and small molecules in clinical development and more than 100 clinical trials underway. By working collaboratively with academic institutions, individual researchers, cooperative research groups, governments, and licensing partners, Pfizer Oncology strives to cure or control cancer with breakthrough medicines, to deliver the right drug for each patient at the right time. For more information please visit www.Pfizer.com .

Pfizer Inc.: Working together for a healthier world(TM)

At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world’s best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world’s leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more about our commitments, please visit us at www.pfizer.com .

(1) World Health Organization.Cancer fact sheet N deg 297. February 2011. Available at: http://www.who.int/mediacentre/factsheets/fs297/en/ . Accessed October 26, 2011.

(2) National Cancer Institute. Lung Cancer. 2011. Available at: http://www.cancer.gov/cancertopics/types/lung . Accessed October 26, 2011.

(3) National Cancer Institute. Surveillance Epidemiology and End Results. SEER Stat Fact Sheets: Lung and Bronchus. Available at: http://seer.cancer.gov/statfacts/html/lungb.html . Accessed October 26, 2011.

(4) American Cancer Society. Detailed Guide: Lung Cancer (Non-Small Cell). 2010. Available at: http://www.cancer.org/acs/groups/cid/documents/webcontent/003115-pdf.pdf . Accessed October 26, 2011.

(5) Reade CA, Ganti AK. EGFR targeted therapy in non-small cell lung cancer: potential role of cetuximab. Biologics: Targets & Therapy. 2009; 3: 215–224.

(6) American Cancer Society. Detailed Guide: Lung Cancer (Non-Small Cell). 2010. Available at: http://www.cancer.org/acs/groups/cid/documents/webcontent/003115-pdf.pdf . Accessed October 26, 2011.

(7) American Cancer Society. Cancer Facts and Figures 2011. Available at: http://www.cancer.org/Research/CancerFactsFigures/CancerFactsFigures/cancer-facts-figures-2011 . Page 15. Accessed November 1, 2011.

SOURCE: Pfizer

Lung Cancer Profiles

Click here for the video http://youtu.be/yxvFW2GYlZ8

There is a blight upon our country. It’s called lung cancer. Mr. President and Mr. Speaker, we urge you to lead us out of this valley of death and despair.
Lung cancer will kill 160,000 of us in 2011. That’s three times more than any other cancer. Among those hardest hit will be the men and women of our armed forces, past and present.
And when it comes to gender equality, lung cancer is an unfortunate area of catch-up, with lung cancer diagnoses among women up six-fold in 30 years. The toll is staggering. More than 70,000 women will die of lung cancer in 2011 – almost 80% more than will die of breast cancer.
Then there is this little known and disturbing fact: one in five women with lung cancer never smoked. That’s twice the rate seen among men with the disease. No one knows why.
We wish we could be hopeful, but while there have been dramatic improvements in the survival rates for many other cancers, the fact is that lung cancer remains a death sentence. The five-year survival rate for stage IV lung cancer – the most common staging at diagnosis – is just four percent, where it was decades ago.
Any way you look at it, lung cancer is a national disaster demanding your attention.
IF NOT YOU, WHO? IF NOT NOW, WHEN?
We are calling on you, Mr. President and Mr. Speaker, to come together – to look beyond partisanship to our common humanity – and to point the way forward in the fight against this dreadful disease. There is so much you can do.
On the legislative side, it is time to pass the Lung Cancer Mortality Reduction Act, which seeks to halve the number of lung cancer deaths by 2020.
You can devote more federal dollars to lung cancer research. Consider that per death, lung cancer receives just a fraction – less than 10% – of the dollars that go to breast or prostate cancer.
You can advocate for public education and for more attention to screening.
And you can take a closer look at the incidence of smoking and lung cancer among our active duty and veteran servicemen and women. It’s the least we can do in defense of those who defend us.
First and foremost, you can drag this killer out from the shadows and declare lung cancer a national health crisis.
THE OPPORTUNITY OF A LIFETIME…YOURS
On a personal level, there is this: For the sake of the nation and of your families, stand up and take a public pledge not to smoke.
Teach us – our children in particular – that smoking is unhealthy. Acknowledge that it is hard to stop but worth the effort. Most importantly, move us past this sorry game of blame-the-victim and help expose the insidious and unspoken notion that because most people who get lung cancer smoked at one time, they somehow “deserve it.”
Mr. President, Mr. Speaker you have a rare and powerful opportunity. Over the next five years, more than 1,000,000 Americans will be diagnosed with lung cancer. You can help save many of them. Do something.

We can all help. Visit www.lungcancerleaders.org today  and encourage President Obama and Speaker Boehner to recognize lung cancer as a national health crisis.