Amgen's First KRAS-Targeted Therapy, Lumakras Scores FDA Approval For Lung Cancer

The FDA has given accelerated approval to Amgen Inc's AMGN Lumakras (sotorasib) for non-small cell lung cancer (NSCLC) patients harboring kras mutation.
The approval covers the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, who have received at least one prior systemic therapy.
Sotorasib is the first KRAS-targeted therapy to be approved after nearly four decades of research, the company said.
The approval is based on the overall response rate (ORR) and duration of response (DoR).
Lumakras demonstrated an ORR of 36% in the trial, with 81% of patients achieving disease control. The median DoR was ten months.
Continued approval for the indication depends on clinical benefit in a confirmatory trial(s).
Amgen has partnered with Guardant Health Inc GH and Qiagen NV QGEN to develop blood- and tissue-based companion diagnostics, respectively, for Lumakras.
Related content: Benzinga's Full FDA Calendar
Price Action: AMGN shares are up 0.40% at $236.26 during the market session on the last check Friday.