OSI reports European recommendation on Tarceva
OSI Pharmaceuticals Inc. said Friday a European advisory committee recommended approval of Tarceva as maintenance treatment for lung cancer patients following multiple rounds of chemotherapy.
The European Committee for Medicinal Products for Human Use recommended that the drug receive approval and the European Commission is expected to make a final decision within 45 days.
The Food and Drug Administration is expected to make a decision on the advanced lung cancer indication by April 18.
Roche is OSI's partner on the drug, which is already approved as a treatment for lung cancer patients whose cancer has spread or grown after receiving one chemotherapy regimen. The drug is also approved for pancreatic cancer.
OSI said the company received $359 million in Tarceva revenue in 2009 and $146 million was related to sales outside the U.S. royalty payments received from Roche for sales outside the U.S.
Shares of OSI rose 30 cents to $59 in premarket trading.