Amgen’s Sotorasib Updates Raise New Questions For KRAS Program
Lower Dose Being Tested Against Higher Dose Under FDA Review
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.
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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.
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
Scrip discussed key wins for sotorasib in lung cancer and tezepelumab in asthma with Amgen executives Murdo Gordon and David Reese, but COVID-19 and other challenges are looming.