With KRAS breakthrough on the horizon, Amgen's David Reese reflects on sotorasib's looming review date and murky future
After decades of failures laid waste to R&D outfits looking to solve the KRAS G12C puzzle, Amgen is as close as anyone ever has been to an approval with sotorasib. For Amgen R&D head David Reese, the drug’s looming review date is a point of reflection for his own career and a big milestone for Amgen’s blooming — if controversial — next-gen oncology pipeline.
Amgen filed its FDA application for sotorasib in December to treat metastatic non-small cell lung cancer with the KRAS mutation — once thought to be “undruggable” — months after the agency offered its breakthrough designation based on pivotal Phase I data showing previously unheard of response rates.
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