LUMAKRAS (sotorasib) receives approval in Japan for lung cancer patients

pharmafile | January 20, 2022 | News story | Business Services  

Amgen has announced that LUMAKRAS received approval in Japan for the treatment of patients with KRAS G12C-mutated advanced non-small cell lung cancer, which has progressed after systemic anticancer therapy.

This approval by the Japan Ministry of Health, Labour and Welfare (MHLW) is based on positive results from the Phase II CodeBreaK 100 clinical trial in NSCLC, which is the largest trial conducted to date for patients with the KRAS G12C mutation. Based on the approved label in Japan, LUMAKRAS 960 mg, orally administered once-daily, demonstrated an objective response rate (ORR) of 37% in 123 evaluable patients.

“Today’s approval of LUMAKRAS as the first and only KRASG12C inhibitor marks a paradigm shift in the treatment of patients with non-small cell lung cancer in Japan,” said David M Reese, MD, executive vice president of Research and Development at Amgen. “In just over three years since the first patient was dosed in the pivotal CodeBreaK 100 trial, LUMAKRAS is now approved in nearly 40 countries, illustrating our commitment to accelerating transformative medicines for patients living with cancers that have yet to be fully addressed.”

KRAS gene mutations are one of the oldest known cancer driver gene mutations,” said Steve Sugino, president and representative director, Amgen KK. “However, it has proven to be very difficult to develop drugs for the treatment of KRAS gene mutations. For nearly 40 years, researchers have said that the mutation was ‘undruggable.’ I am very pleased that LUMAKRAS is now approved as a new treatment option for patients in Japan.”

Lina Adams

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