CORRECTED - UPDATE 1-US FDA staff: Tarceva effective for wider use

Mon Dec 14, 2009 9:00am EST

(Corrects day of advisory panel meeting in paragraph 6 to Wednesday from Tuesday)

WASHINGTON Dec 14 (Reuters) - Tarceva, co-marketed by Roche Holding AG (ROG.VX) and OSI Pharmaceuticals OSIP.O met the main goals in a study testing effectiveness when given to lung cancer patients immediately after chemotherapy, U.S. drug reviewers said in documents released on Monday.

Food and Drug Administration staff who reviewed OSI's application to market the drug for that use said "the main issue concerns other available treatment options" for patients who have just finished chemotherapy without their disease getting worse.

Both Tarceva and another drug, docetaxel, have been shown to improve survival of lung cancer patients by about three months when started after their disease has progressed.

When started just after chemotherapy, the improvement in median survival was one month over a placebo.

"This raises the question whether treatment with single agent (Tarceva) or docetaxel after progression are better options," FDA reviewers said.

On Wednesday, the agency will ask an advisory panel for input on OSI's application to market Tarceva for the wider use.

Sanofi-Aventis (SASY.PA) sells docetaxel under the brand name Taxotere. (Reporting by Lisa Richwine, editing by Dave Zimmerman)

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