Sotorasib Earns Approval in Japan for KRAS G12C+ NSCLC


The Japan Ministry of Health, Labour and Welfare granted approval to the KRAS inhibitor sotorasib for the treatment of adults with KRAS G12C–mutated non–small cell lung cancer.

Patients with KRAS G12C–positive unresectable, advanced, or recurrent non–small cell lung cancer (NSCLC) who have received prior therapy can now be treated with sotorasib (Lumakras) in Japan, according to the drug developer Amgen.

Approval by the Japan Ministry of Health, Labour and Welfare (MHLW) is based on data from the phase 2 CodeBreaK100 trial (NCT03600883) in which the selective KRAS G12C inhibitor was able to elicit durable clinical benefit in patients with NSCLC harboring a KRAS G12C mutation.

“Today’s approval of Lumakras as the first and only KRAS G12C 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 3 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.”

Results of the pivotal trial were presented at the 2021 American Society of Clinical Oncology Annual meeting showing an objective response rate of 37% in patients with locally advanced or metastatic KRAS G12C mutation­–positive NSCLC as assessed by central testing of tumor biopsies. Patients received sotorasib orally at 960 mg once daily until disease progression.

“The prognosis for patients with non­–small cell lung cancer who have distant metastases or whose disease has relapsed after surgery, is generally poor,” Tetsuya Mitsudomi, MD, professor in the Department of Surgery, Division of Thoracic Surgery at Kindai University School of Medicine, and past-president of both the International Association for the Study of Lung Cancer the Japan Lung Cancer Society, said in a press release. “Recent developments in molecular-targeted drugs and immunotherapy have dramatically improved the prognosis for these patients. However, despite the relatively high frequency of the KRAS G12C mutation, no drugs specifically targeting this mutation have been available until recently. Therefore, the approval of Lumakras in Japan is a major milestone in the treatment of non–small cell lung cancer patients with KRAS G12C mutations.”

Sotorasib was previously granted orphan drug designation by the MHLW in March 2021. The agent is approved for a similar indication by the FDA.


Lumakras (sotorasib) receives approval in Japan for patients with KRAS G12C-mutated advanced non-small cell lung cancer. News release. Amgen. January 20, 2022. Accessed January 20, 2022.

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