This approval marks the first approved targeted therapy for tumors with any KRAS mutation. KRAS mutations account for approximately 25% of mutations in NSCLC and KRAS G12C mutations account for about 13% 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. “Today’s approval represents a significant step towards a future where more patients will have a personalized treatment approach.”
The FDA based the approval on results from the Lumakras trial, which included 124 patients with KRAS G12C mutated NSCLC who received at least one prior therapy.
Researchers reported an objective response rate of 36% among those treated with sotorasib. Overall, 58% of patients had a duration of response of six months or longer.
The most common side effects of Lumakras include diarrhea, musculoskeletal pain, nausea, fatigue, liver damage and cough.
Sotorasib was granted accelerated approval, therefore a postmarketing trial is required to confirm results.
By Cassie Homer
