The shadow of Iressa lingered over the FDA Oncologic Drugs Advisory Committee as the panel voted down Genasense (Genta Inc.) and RSR13 (Allos Therapeutics Inc.) at its May 3 meeting. If anyone thought the bar had been lowered for drug approvals, they were mistaken.
Progression-free survival as a primary endpoint for drug approval requires prospective planning, FDA’s Pazdur says.
FDA developing guidelines for oncology endpoints.
Also in this 8-page issue: NIH Conflict of Interest panel recommends that NIH employees should not receive stock options or equities as compensation for outside work.
Michelle Le Beau named director of University of Chicago Cancer Research Center.
