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Genentech/OSI Tarceva sNDA

Executive Summary

FDA's Oncologic Drugs Advisory Committee will review on Sept. 13 Genentech/OSI's Tarceva sNDA (21-743/S003) for first-line treatment, in combination with gemcitabine (Lilly's Gemzar), of patients with locally advanced, unresectable or metastatic pancreatic cancer. The estimated user fee deadline for the sNDA is Nov. 2. Tarceva (erlotinib) was approved in November 2004 for locally advanced or metastatic non-small cell lung cancer (1"The Pink Sheet" Nov. 29, 2004, p. 4). The meeting will be at the Holiday Inn in Bethesda, Md. at 8 a.m. [Editor's Note: To 2watch a webcastor order a video/DVD of this meeting, visit FDAAdvisoryCommittee.com.]...

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