Benzinga | May 28, 2021 02:29PM EDT

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

* The FDA has given accelerated approval to Amgen Inc's (NASDAQ: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 (NASDAQ:GH) and Qiagen NV (NYSE: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.