FDA approves a new cancer drug, Vidaza, and two sNDAs, without going to ODAC. A date with ODAC may signal a weak case for drug approval, recent approval data indicate.
Also in this 8-page issue: Cooperative groups tell Congress that NCI’s $115 million in support for adult cancer clinical trials is “chump change.” Trials would close faster, report results sooner, if funding were increased, regulatory issues streamlined.
Larry Norton wins ASCO’s Karnofsky award.
Funding opportunities listed.
May issue of Business & Regulatory Report, 8 additional pages, included.
Trending Stories
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Problem: “Breast density is in the eye of the mammographer” - ODAC votes overwhelmingly in support of PD-L1 expression as predictive biomarker for efficacy of checkpoint inhibitors
Vote applies across drugs and indications - Undergrad intern at MSK poses a profound question: What if Henrietta Lacks had a Black doctor?
- Jeffrey Weber on his career, mentors: “Never ever ever ever blow your cool.”
- NCI-designated Basic Laboratory Cancer Centers get research done—efficiently
- Tom Lynch reflects on discovery of the EGFR mutations’ role in lung cancer