OSI Pharma, Genentech Seek New Tarceva Approval

NEW YORK (AP) — OSI Pharmaceuticals Inc. and Genentech Inc. said Thursday they asked regulators in the U.S. and Europe to approve their cancer drug Tarceva as part of a first line of treatment for lung cancer. The companies asked the U.S. Food and Drug Administration to approve marketing of Tarceva as a first-line maintenance therapy, or a treatment intended to stop the spread of cancer in patients whose disease did not advance during chemotherapy. Their partner, the Swiss drug maker Roche, asked for the same approval from the European Medicines Agency. Tarceva is a daily pill, and is already approved as a secondary treatment for non-small cell lung cancer, meaning it is used for patients who have not responded to previous chemotherapy. It can also be marketed as a first-line treatment for pancreatic cancer. In February, OSI forecast $1.2 billion in Tarceva sales this year. The drug is made by Melville, N.Y.-based OSI and sold in partnership with South San Francisco-based Genentech.