FDA Approves Sotorasib for KRAS G12-Mutant NSCLC


Sotorasib is the first targeted therapy approved for KRAS-mutant non-small cell lung cancer.

The FDA approved sotorasib (Lumakras) for the treatment of patients with non-small cell lung cancer (NSCLC) whose tumor have a KRAS G12C mutation and have received 1 or more prior systemic therapy. The approval marks the first targeted therapy for KRAS-mutant tumors, which account for about 25% of mutations in NSCLC.

“KRAS mutations have long been considered resistant to drug therapy, representing a true unmet need for patients with certain types of cancer,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, in a statement.

The approval is based on findings from a clinical trial including 124 patients with locally advanced or metastatic KRAS G12C-mutant NSCLC whose disease progressed after treatment with a checkpoint inhibitor and/or platinum-based chemotherapy. Patients on sotorasib had a 36% objective response rate, and 58% of them had a duration of response that lasted 6 months or longer.

The FDA approved a 960 mg dose of the drug, and since it was granted an accelerated approval, the agency will conduct a post-marketing trial to determine if a lower dose has a similar clinical effect.

Common adverse events seen in patients taking sotorasib include musculoskeletal pain, nausea, fatigue, liver damage, and cough.

If a patient develops symptoms of interstitial lung disease, sotorasib should be withheld. If interstitial lung disease is confirmed, the drug should be stopped permanently. Additionally, if a patient develops liver damage, sotorasib should be withheld, dose-reduced, or permanently discontinued.

Patients should not take acid-reducing agents, drugs that induce or are substrates for certain liver enzymes, and drugs that are substrates of the P-glycoprotein while they are taking sotorasib.

“Today’s approval represents a significant step towards a future where more patients will have a personalized treatment approach,” Pazdur said.


FDA. FDA Approves First Targeted Therapy for Lung Cancer Mutation Previously Considered Resistant to Drug Therapy. May 28, 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-first-targeted-therapy-lung-cancer-mutation-previously-considered-resistant-drug#:~:text=Today%2C%20the%20U.S.%20Food%20and,least%20one%20prior%20systemic%20therapy.

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