- 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.
© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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