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.
Funding opportunities listed.
Trending Stories
- HHS Secretary Kennedy’s diet advice is heavy on meat and light on scientific consensus
- Mt. Sinai forms committee to probe Epstein links to breast center founder Eva Dubin, other faculty members
- Gonzalez-Angulo Found Guilty In MD Anderson Poisoning Case
- “This is not about protecting life”: Supreme Court overturn of Roe v. Wade threatens lives of cancer patients, doctors
- FDA’s guidance on MRD in MM goes beyond the ODAC vote—and that’s where it matters most
Draft guidance consolidates trial design updates for developers - HHS presents new protein-forward dietary guidelines, turning the food pyramid upside down
The Kennedy guidelines are mum on cancer risks associated with red meat and alcohol
