Amgen's Lumakras Approved In Japan For Pretreated Lung Cancer Patients

Amgen Inc's AMGN Lumakras (sotorasib) has been approved in Japan for KRAS G12C-mutated positive, unresectable, advanced and/or recurrent non-small cell lung cancer (NSCLC) progressed after systemic anticancer therapy.

• Lumakras is now approved in nearly 40 countries.
• Related: Europe Approves Amgen's KRAS-Targeted Lung Cancer Therapy.
• The approval is based on positive results from the Phase 2 CodeBreaK 100 clinical trial that showed Lumakras 960 mg demonstrated an objective response rate (ORR) of 37% in 123 evaluable patients (including 10 Japanese patients).
• Last week, Amgen and Arrakis Therapeutics announced a research collaboration focused on discovering and developing RNA degrader therapeutics. 
• Under the terms of the agreement, Arrakis will lead research activities to identify RNA-targeted small molecule binders against targets nominated by Amgen. 
• Amgen will lead further preclinical and clinical development activities. 
• Amgen will pay $75 million upfront to Arrakis for five initial programs and will have the option to nominate additional programs. 
• Price Action: AMGN shares are up 0.82% at $233.19 during the premarket session on the last check Thursday.