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FDA posts Tarceva briefing documents

December 15, 2009 3:22 AM UTC

FDA posted briefing documents ahead of Wednesday's meeting of the Oncologic Drugs Advisory Committee to discuss an sNDA from OSI Pharmaceuticals Inc. (NASDAQ:OSIP) for Tarceva erlotinib for first-line maintenance treatment of advanced non-small cell lung cancer (NSCLC). The maintenance indication includes patients whose disease has not progressed following platinum-based chemotherapy.

Although Tarceva met the Phase IIIb SATURN trial's co-primary endpoints of progression-free survival (PFS) in the total study population and in the EGFR-positive subgroup, FDA focused much of its analysis on overall survival (OS), a secondary endpoint. FDA questioned whether the drug is better used after progression, because it produced only a one-month improvement in OS over placebo in the maintenance trial, compared with previous studies that showed a three-month improvement when given after failure of chemotherapy. The small molecule EGFR inhibitor is approved for second-line use after failure of chemotherapy. ...