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.
