Amgen's LUMAKRAS approved in Japan for the treatment of non-small cell lung cancer patients with KRAS G12C mutations
Amgen (NASDAQ:AMGN)
announced that LUMAKRAS (sotorasib) has been approved by the Japan Ministry of Health, Labour and Welfare (MHLW) for the treatment of KRAS G12C-mutated positive, unresectable, advanced and/or recurrent non-small cell lung cancer (NSCLC) that has progressed after systemic anticancer therapy.
The approval is based on positive results from the Phase 2 CodeBreaK 100 clinical trial in NSCLC.
This was the largest trial conducted to date for patients with the KRAS G12C mutation.
n May 2021, LUMAKRAS was the first KRAS G12C inhibitor to receive regulatory approval anywhere in the world with its approval in the U.S., under accelerated approval. It is also approved in the United Arab Emirates, the European Union and Switzerland, and in Canada and Great Britain under the FDA's Project Orbis.