Non-small cell lung cancer

Executive Summary

FDA's Oncologic Drugs Advisory Committee will consider appropriate endpoints for non-small cell lung cancer clinical trials at a Dec. 16 meeting, as part of the agency's ongoing 1project on cancer endpoints. The meeting will follow up on an April 15 workshop, where FDA noted most oncology approvals are not based on survival endpoints (2"The Pink Sheet" April 21, 2003, p. 25). ODAC will also discuss "general issues on [cancer] clinical trial design and endpoints." The meeting will be held at the Holiday Inn in Bethesda, Md. beginning at 8 a.m. [To watch a 3webcast of this meeting, go to FDAAdvisoryCommittee.com]....