US FDA Plans To Get Tougher On Oncology Dose Optimization
FDA’s Rick Pazdur notes that while the agency recently allowed Amgen to conduct a key dose comparison study for its landmark KRAS inhibitor post-market it will be less willing to do this in the future, particularly in settings that are less refractory.
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US FDA is open to keeping COVID-necessitated trial changes that may have had unexpected benefits. The agency is also looking at building on pandemic’s focus on health disparities and inequities to push for more generalizable and inclusive clinical trial designs.
Keeping Track: US FDA Approves Amgen’s Lumakras, Myovant’s Myfembree; New Claims For Biohaven’s Nurtec, BMS’ Zeposia
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
The company provided updates on the timing of some data from its extensive clinical program for its KRAS G12C inhibitor Lumakras, but not for certain high-profile combinations.