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
- Maura Gillison, who identified the role of HPV in head and neck cancer, changing the standard of care, dies at 61
- How will FDA regulate psychedelics?
- Cancer hospitals brace for impact, as CMS moves to slash 340B payments by 33%
- Mail-out colorectal cancer screening programs extend, rather than replace, clinical care
- Vermont researchers discover transmissible cancer in catfish—first ever in a freshwater animal
- The Directors: Two leaders in data science have a warp speed vision for AI, with cancer clinical trials leading the way
Knudsen and Thoelke: “It’s actually solving for bottlenecks and challenges that we’ve been unable to overcome for so long”









