OSI/Genentech gain additional indication from US FDA for Tarceva as maintenance therapy for advanced NSCLC

USA-based OSI Pharmaceuticals, which is fending off a hostile $3.5 billion takeover bid from Japan's Astellas, received welcome news last Friday, when the Food and Drug Administration approved the daily pill Tarceva (erlotinib) as a maintenance treatment for patients with locally advanced-or metastatic non-small cell lung cancer whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.

The FDA decision was not totally anticipated as, just last December, an FDA advisory panel voted 12 to one against approval of the new indication, arguing a one-month prolonged survival shown with Tarceva as an initial maintenance treatment was only a "modest improvement" over the three-month survival benefit when the medicine is taken after chemotherapy fails.

Tarceva, which is marketed outside the USA by Swiss drug major Roche and its wholly-owned US subsidiary Genentech, generated first-quarter 2010 sales of 326 million Swiss francs ($304.9 million), up 6% on the like 2009 period, in its current indications (The Pharma Letter April 15). The drug accounted for 83% of OSI's revenue in 2009, with sales of $208 million and royalty revenue of $146 million from Roche.