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FDA Grants Genentech’s Alecensa Priority Review for Initial Treatment of People with ALK-Positive Lung Cancer South San Francisco, CA -- August 2, 2017 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) and granted Priority Review for Alecensa® (alectinib) as an initial (first-line) treatment for people with anaplastic lymphoma kinase (ALK)-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. The FDA will make a decision on approval by November 30, 2017. “Phase III results showed Alecensa reduced the risk of disease worsening by more than half compared to the current standard of care and lowered the risk of tumors spreading to or growing in the brain by more than 80 percent,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We are working closely with the FDA to bring this medicine as an initial treatment for people with ALK-positive NSCLC as soon as possible.” This sNDA submission for Alecensa is based on results from the Phase III ALEX and Phase III J-ALEX studies. A Priority Review designation is granted to proposed medicines that, if approved, the FDA has determined to have the potential to provide a significant improvement in the safety or effectiveness of the treatment, prevention or diagnosis of a serious disease. Alecensa received Breakthrough Therapy Designation from the FDA in September 2016 for the treatment of adults with advanced ALK-positive NSCLC who have not received prior treatment with an ALK inhibitor. Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases and to help ensure people have access to them through FDA approval as soon as possible. Breakthrough Therapy Designation was granted on the basis of the Phase III J-ALEX trial. Alecensa was granted accelerated approval by the FDA in December 2015 for the treatment of people with ALK-positive metastatic NSCLC who have progressed on or are intolerant to crizotinib. The ALEX study is part of the company’s commitment in the U.S. to convert the current accelerated approval of Alecensa in people with ALK-positive, metastatic NSCLC who have progressed on or are intolerant to crizotinib to a full approval as an initial treatment. Read the full press release here.-
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For ALK: "FDA Grants Genentech’s Alecensa® (Alectinib) Accelerated Approval for People with a Specific Type of Lung Cancer " http://www.gene.com/media/press-releases/14615/2015-12-11/fda-grants-genentechs-alecensa-alectinib -
LUNGevity Foundation Applauds FDA Approval of Immunotherapy Drug Opdivo Print this page New Therapy Will Harness the Power of Patients’ Own Immune Systems to Fight Lung Cancer FOR IMMEDIATE RELEASE Media Contact: Aliza Bran abran@susandavis.com (202) 414-0798 WASHINGTON (March 2015) – LUNGevity Foundation, the nation’s leading lung cancer nonprofit, applauds the Food and Drug Administration’s (FDA) approval of Bristol Myers Squibb’s new immunotherapy drug Opdivo (nivolumab). Opdivo and other immunotherapy treatments add another critical new treatment option to fight lung cancer by harnessing the power of a patient’s own immune system to fight cancerous cells. Importantly, this drug has been approved specifically for patients with squamous cell lung cancer, a population for which there have been few new treatment options. “The FDA approval of Bristol Myers Squibb’s new drug Opdivo is an important step in bringing this game-changing treatment to patients nationwide,” said Andrea Ferris, president and chairman of LUNGevity Foundation. “We are thrilled to have a new tool in the kit of treatment options for our lung cancer community. There is still a lot of work to be done in understanding the true impact of the treatment over the long term, but this is a very exciting development.” LUNGevity has been an ongoing investor in accelerating promising and innovative lung cancer research that helps find and treat the disease more effectively, including in the expanding field of immunotherapy. “Immunotherapy is transforming the lung cancer treatment paradigm, providing the most promising option yet in the second-line treatment for squamous cell lung cancer patients,” said Dr. Julie Brahmer, MD, LUNGevity scientific advisory board member and thoracic cancer director at Johns Hopkins Kimmel Cancer Center, and associate professor of oncology at Johns Hopkins. “There’s still work to be done to determine which immunotherapy can best help which patient and which treatment combinations are most successful. The results of the Opdivo trials show the critical importance of lung cancer research and the extraordinary power of collaboration of researchers, physicians, and patients. The concurrence of patient and research interests has expedited the process behind this treatment from basic research to clinical trials to the initial step toward immunotherapy existing as the primary treatment for lung cancer. This is just the tip of the iceberg.” Dr. David Carbone, MD, PhD, LUNGevity scientific advisory board member and director of the thoracic oncology center at The Ohio State University, concurs. “The revolutionary new field of immunotherapy has completely transformed the way we treat and understand the disease. While not a panacea for everyone, immunotherapy is a quantum leap for lung cancer treatments, and will only show more promise as research continues to unveil innovative and exciting ways to tap the potential of this therapy.” For more information on LUNGevity Foundation, please visit www.LUNGevity.org. About Lung Cancer 1 in 15 Americans will be diagnosed with lung cancer in their lifetime More than 221,000 people in the US will be diagnosed with lung cancer this year About 60% of all new lung cancer diagnoses are among people who have never smoked or are former smokers Lung cancer kills more people than the next three cancers (colorectal, breast, and pancreatic) combined Only 17% of all people diagnosed with lung cancer will survive 5 years or more, BUT if it’s caught before it spreads, the chance for 5-year survival improves dramatically About LUNGevity Foundation LUNGevity Foundation is firmly committed to making an immediate impact on increasing quality of life and survivorship of people with lung cancer by accelerating research into early detection and more effective treatments, as well as by providing community, support, and education for all those affected by the disease. Our vision is a world where no one dies of lung cancer. For more information about LUNGevity Foundation, please visit www.LUNGevity.org. http://lungevity.org/about-us/media-resources/news-from-foundation/lungevity-foundation-applauds-fda-approval-of
