4/19/2017
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`Astellas Pharma US, Inc. | News Room - News Releases
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`News Releases
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`OSI Pharmaceuticals Announces That Tarceva® Received Approval in the European Union for
`Maintenance Use in Advanced Non-Small Cell Lung Cancer
`MELVILLE, N.Y., Apr 29, 2010 (BUSINESS WIRE) -- OSI Pharmaceuticals, Inc. (Nasdaq: OSIP) announced today that its international
`partner for Tarceva® (erlotinib), Roche, received approval from the European Commission for Tarceva as a monotherapy
`maintenance treatment in patients with advanced non-small cell lung cancer (NSCLC) whose disease remains largely unchanged
`(stable disease) after platinum-based initial chemotherapy.
`"We are pleased that the European health authorities recognize Tarceva as a valuable option for lung cancer patients and their
`physicians when used in the first-line maintenance setting," said Colin Goddard, Ph.D., Chief Executive Officer of OSI
`Pharmaceuticals. "We look forward to working with our partner, Roche, to advance the robust Tarceva lifecycle program, which
`includes evaluating Tarceva in the adjuvant setting and as a first-line treatment for advanced NSCLC patients with an activating EGFR
`mutation as well as branching into other disease settings including liver cancer."
`OSI previously announced on April 16, 2010 that the U.S. Food and Drug Administration (FDA) approved Tarceva as a maintenance
`treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has not progressed
`after four cycles of platinum-based first-line chemotherapy. Tarceva is now approved in 109 countries for advanced NSCLC and 80
`countries for pancreatic cancer.
`About SATURN
`The EU approval was based on data from the pivotal Phase III SATURN study. SATURN was an international, placebocontrolled,
`randomized, double-blinded, Phase III study that enrolled 889 patients with advanced NSCLC at approximately 160 sites worldwide.
`Patients were treated with four cycles of standard first-line platinum-based chemotherapy and then randomized to Tarceva or placebo
`if the cancer did not progress. SATURN showed that Tarceva given as a maintenance therapy immediately after first-line
`chemotherapy significantly extended overall survival (OS) and significantly improved the time people with advanced NSCLC lived
`without the disease getting worse (progression-free survival, PFS) in a broad patient population, including squamous and non-
`squamous histology, compared with placebo.
`About Lung Cancer
`Lung cancer is the most common cancer worldwide with 1.5 million new cases annually and NSCLC accounts for almost 85% of all
`lung cancers. NSCLC progresses rapidly; less than 5% of advanced NSCLC patients survive for five years.
`About Tarceva
`Tarceva is a once-a-day pill that targets the EGFR pathway. Tarceva is designed to inhibit the tyrosine kinase activity of the EGFR
`signaling pathway inside the cancer cell, one of the critical growth factors in NSCLC and pancreatic cancer. The way Tarceva works to
`treat cancer is not fully known. Tarceva is prescribed for patients with advanced-stage NSCLC whose cancer has grown or spread
`after initial treatment with certain types of chemotherapy. Tarceva is also prescribed for people with advanced-stage NSCLC whose
`cancer has not grown or spread after receiving at least one chemotherapy regimen. Tarceva is not meant to be used at the same time
`as certain types of chemotherapy for NSCLC. In pancreatic cancer, Tarceva in combination with gemcitabine is prescribed for patients
`with advanced-stage pancreatic cancer whose cancer has spread, grown, or cannot be surgically removed, and who have not
`received previous chemotherapy.
`Tarceva Safety
`There have been reports of serious Interstitial Lung Disease (ILD)-like events including deaths in patients taking Tarceva. Serious
`side effects (including deaths) in patients taking Tarceva include liver and/or kidney problems; gastrointestinal (GI) perforations (the
`development of a hole in the stomach, small intestine, or large intestine); and severe blistering skin reactions including cases similar
`to Stevens-Johnson syndrome. Patients taking Tarceva plus gemcitabine were more likely to experience bleeding and clotting
`problems such as heart attack or stroke. Eye irritation and damage to the cornea have been reported in patients taking Tarceva.
`Difficulty with blood clotting, and bleeding events, including gastrointestinal and non-gastrointestinal bleeding, have been reported in
`clinical studies. Women should avoid becoming pregnant and avoid breastfeeding while taking Tarceva. Patients should call their
`doctor right away if they have these signs or symptoms: new or worsening skin rash; serious or ongoing diarrhea, nausea, loss of
`appetite, vomiting or stomach pain; new or worsening shortness of breath or cough; fever; eye irritation. Rash and diarrhea were the
`most common side effects associated with Tarceva in the NSCLC clinical studies. Fatigue, rash, nausea, loss of appetite and diarrhea
`were the most common side effects associated with Tarceva plus gemcitabine therapy in the pancreatic cancer clinical study.
`For full prescribing information, please call 1-877-TARCEVA or visit http://www.tarceva.com.
`About OSI Pharmaceuticals
`OSI Pharmaceuticals is committed to "shaping medicine and changing lives" by discovering, developing and commercializing high-
`quality, novel and differentiated targeted medicines designed to extend life and improve the quality of life for patients with cancer and
`diabetes/obesity. For additional information about OSI, please visit http://www.osip.com.
`This news release contains forward-looking statements. These statements are subject to known and unknown risks and uncertainties
`that may cause actual future experience and results to differ materially from the statements made. Factors that might cause such a
`difference include, among others, OSI's and its collaborators' abilities to effectively market and sell Tarceva and to expand theOSI 2037
`http://newsroom.astellas.us/news-releases?item=122283#
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`Astellas Pharma US, Inc. | News Room - News Releases
`4/19/2017
`approved indications for Tarceva, OSI's ability to protect its intellectual property rights, safety concerns regarding Tarceva, competition
`to Tarceva and OSI's drug candidates from other biotechnology and pharmaceutical companies, the completion of clinical trials, the
`effects of FDA and other governmental regulation, including pricing controls, OSI's ability to successfully develop and commercialize
`drug candidates, and other factors described in OSI Pharmaceuticals' filings with the Securities and Exchange Commission.
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`http://newsroom.astellas.us/news-releases?item=122283#
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