Amgen Wins World-First Lumakras Approval, Faces Challenge Of COVID-Era Launch

Amgen, Inc. has secured a several month lead with its newly approved Lumakras (sotorasib) as the only KRAS G12C inhibitor available in the US before its likely first competitor, adagrasib from Mirati Therapeutics, Inc., hits the market. Even so, Amgen executive vice president of global commercial operations Murdo Gordon told Scrip that the company still faces the tough challenge of launching its new drug during the COVID-19 pandemic.

The US Food and Drug Administration approved Lumakras (sotorasib) on 28 May for the treatment of KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, in patients who received at least one prior systemic therapy. As the first oncologic to target KRAS, which has long been a goal of cancer drug development, it will be a notable launch. KRAS is a well-known driver mutation in lung cancer and other solid tumors types, discovered more than 40 years ago, but until recently was difficult to drug