US FDA panel turns down extended use of OSI/Genentech/Roche's Tarceva

The US Food and Drug Administration Oncologic Drugs Advisory Committee yesterday voted nearly unanimously (12 to one) against recommending approval of daily Tarceva (erlotinib) for first-line maintenance use in people with advanced or metastatic non-small cell lung cancer (NSCLC) whose cancer has not progressed following first-line treatment with platinum-based chemotherapy.

The drug, which was licensed by developer OSI Pharmaceuticals to US biotechnology giant Genentech, now wholly-owned by Swiss major Roche, is currently approved to treat non-small cell lung cancer after treatment with chemotherapy failed to stop the spread of the disease. The FDA is not bound by the recommendations of its advisory committees and the agency is expected to make a decision whether to approve Tarceva for this use by January 18, 2010.

Melville, New-York-based OSI saw its shares plunge 7.1% $32.89 at 4 pm EST-time in Nasdaq trading. It was the company's biggest single-day decline since June 1. Earlier, Roche added 2.8%, to close at $174.5 francs in Zurich.