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Biotech / Medical : OSI Pharmaceuticals (OSIP) - formerly Oncogene -- Ignore unavailable to you. Want to Upgrade?

To: tuck who wrote (259)	9/21/2005 10:59:58 AM
From: tuck	Respond to of 447

European Approval of tarceva for NSCLC: >>MELVILLE, N.Y.--(BUSINESS WIRE)--Sept. 21, 2005--OSI Pharmaceuticals, Inc. (NASDAQ:OSIP - News) announced today that its international partner for Tarceva® (erlotinib), Roche, received approval from the European Commission of Tarceva for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. Tarceva is an oral tablet indicated for daily administration, and is approved in the United States, Canada, and Switzerland. Tarceva is the only epidermal growth factor receptor (EGFR) therapy to demonstrate in a Phase III trial an increase in survival for advanced NSCLC patients. "We are pleased that lung cancer patients in the European Union now have a new treatment option with a proven survival benefit, coupled with a manageable side effect profile," said Colin Goddard, Ph.D., Chief Executive Officer of OSI Pharmaceuticals. "We congratulate our partner, Roche, on their efforts, and continue to work closely with both Roche and Genentech to explore additional uses of Tarceva in solid tumors and in combination with other therapies." The European Commission approved Tarceva for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen. When prescribing Tarceva, factors associated with prolonged survival should be taken into account. No survival benefit or other clinically relevant effects of the treatment have been demonstrated in lung cancer patients with EGFR-negative tumors. The EU approval is based on data from a pivotal Phase III study, Trial BR.21, which was recently published in The New England Journal of Medicine. The study compared Tarceva to placebo for the treatment of patients with advanced NSCLC, following failure of first or second-line chemotherapy. As with the U.S., Swiss, and Canadian approvals, no mandatory testing for EGFR is required. "Despite being the biggest cancer killer, lung cancer is an often neglected disease," said Dr. Giuseppe Giaccone, VU Medical Center, Amsterdam. "Over 50 percent of lung cancer patients in Europe are not receiving second-line treatment. With the approval of Tarceva, physicians now have a viable alternative to chemotherapy for their patients." About Non-Small Cell Lung Cancer According to the World Health Organization, lung cancer is the most common cancer worldwide with 1.2 million new cases annually with someone, somewhere dying of the disease every 30 seconds. NSCLC accounts for almost 80 percent of all lung cancer cases, and there are few treatment options available. There are an estimated 370,000 people suffering with lung cancer each year in Europe. << snip Cheers, Tuck