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
- Oncologist Rachna Shroff endows award to outlast her cancer diagnosis
“Because of my health, I have a profound desire to see this endowment come to fruition now” - Is it time to re-assess the practice and practicality of screening colonoscopy?
Modeling data, ACS guideline support greater use of noninvasive tests to ease system strain, help save lives - Letai: MCEDs are a “great ideal”—alas, the data don’t support widespread use
“Projecting sub-ideal tests across a large population can cause harm,” Letai says, as Galleri cruises toward FDA approval - As FDA sidesteps the question of Galleri’s clinical benefit, NCI’s Letai has “some concerns”
- From “default dead” to living the future of cancer care
As founding CEO of GitLab, I went “founder mode” on my osteosarcoma - Oncology has a semantics problem: How do we define “early stage”?
