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FDA Approvals, News & UpdatesLung Cancer

Lumakras First FDA-Approved Drug for Advanced Lung Cancer and KRAS G12C Mutation

In May 2021, the FDA approved Lumakras (sotorasib), an oral KRAS inhibitor, for the treatment of adults with locally advanced or metastatic non–small-cell lung cancer associated with KRAS G12C mutation. Lumakras is the first drug approved for any cancer associated with any KRAS mutation.
June 2021 Vol 7 No 3

In May 2021, the FDA accelerated the approval of Lumakras (sotorasib; from Amgen), an oral KRAS inhibitor of the RAS GTPase family, for the treatment of adults with locally advanced or metastatic non–small-cell lung cancer (NSCLC) associated with KRAS G12C mutation, as determined by an FDA-approved test, after at least 1 systemic therapy.

Lumakras is the first drug approved by the FDA for the treatment of any cancer associated with any KRAS mutation, a type of mutation that was thought to be resistant to any drug therapy. Approximately 25% of mutations found in patients with NSCLC are KRAS mutations, and approximately 13% of NSCLC-related mutations are KRAS G12C mutations.

KRAS mutations have long been considered resistant to drug therapy, representing a true unmet need for patients with certain types of cancer. Today’s approval represents a significant step toward a future where more patients will have a personalized treatment approach,” said Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence.

This approval was based on a study of 124 patients with locally advanced or metastatic NSCLC and KRAS G12C mutation that progressed after treatment with an immune checkpoint inhibitor and/or platinum-based chemotherapy. In all, 36% of the patients had a response to treatment with Lumakras, and the response to therapy lasted 6 months or more in 58% of the patients who had a response.

The most common side effects with Lumakras include diarrhea, musculoskeletal pain, nausea, fatigue, liver damage, and cough.

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Last modified: July 6, 2021

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