Biotech Values

[DewDiligence]

AMGN—FDA approves Lumakras—(f/k/a AMG-510)—for_second-line KRAS-mutated NSCLC:

https://finance.yahoo.com/news/fda-approves-lumakras-sotorasib-first-164700884.html

Amgen today announced that the U.S. Food and Drug Administration (FDA) has approved LUMAKRAS (sotorasib) for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.

LUMAKRAS has received accelerated approval based on overall response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

The next goal for AMGN is to obtain approval in the first-line setting.