FDA approval of Amgen drug sotorasib (Lumakras) makes the small molecule the first compound authorized by the regulator for treating cancers characterized by a KRAS G12C mutation. Mutated KRAS proteins had long been regarded "undruggable" targets.
The company did not provide data, but said results for patients who received sotorasib at the 960mg dose were consistent with those seen in the Phase I portion of the Phase I/II study, which showed an overall response rate of 35.3%. ......
In a recent interview, Esperion president and CEO, Sheldon Koenig talks about the reality of statin intolerance and his company’s expansion into new diseases
Sotorasib, a KRAS G12C inhibitor, showed an overall response rate and duration of response that analysts called approvable, but they noted the results have waned over time, and combinations may be the way forward.
An investigator in the Phase I/II trial of Amgen's AMG 510 said that while data for colorectal cancer indicated low activity as a single agent, it nevertheless represented a doubling in progression-free survival over what is seen from currently available treatments.