OSI Pharmaceuticals Announces That Tarceva® Received A Positive Opinion From Health Authorities In The European Union For First-Line Maintenance Use In Advanced Non-Small Cell Lung Cancer
OSI Pharmaceuticals, Inc. (Nasdaq: OSIP) announced today that its international partner for Tarceva ® (erlotinib), Roche, informed OSI that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Tarceva as monotherapy for maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with stable disease following four cycles of standard platinum-based first-line chemotherapy. A final decision is expected from the European Commission within 45 days.
“Advanced lung cancer is an aggressive disease and when the cancer grows or spreads the health of patients deteriorates rapidly. By giving Tarceva earlier after chemotherapy, instead of waiting for the disease to progress, we could help more people live longer without their disease getting worse,” said Professor Federico Cappuzzo, M.D., Head of Oncology Unit, Livorno Hospital, Italy and principal investigator of the SATURN trial.
The CHMP positive opinion is based on a review of data from the pivotal Phase III SATURN study which showed a statistically significant improvement in both progression-free survival (PFS) and overall survival (OS)- the study’s primary and secondary endpoints, respectively- with Tarceva compared to placebo across a broad range of patients with advanced NSCLC in the maintenance setting. The magnitude of the benefit was greater in patients with stable disease following first-line chemotherapy compared to patients achieving a complete or partial response. Data for patients with stable disease will be presented at a forthcoming scientific meeting.
The U.S. Food and Drug Administration (FDA) recently extended the review period for the supplemental New Drug Application (sNDA) for Tarceva as a first-line maintenance therapy in advanced NSCLC by 90 days, and the agency is now expected to make a decision by April 18, 2010.Sales of Tarceva outside the U.S. represent an important component of the Company's revenues. In 2009, $146 million (or 41%) of the Company's $359 million in Tarceva-related revenues were derived from royalty payments received from Roche for sales outside the U.S. market.
Select the service that is right for you!COMPARE ALL SERVICES
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV