FDA approves sotorasib for lung cancer subset
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The FDA has approved sotorasib for use in adults with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer who have received at least one prior systematic therapy.
This is the first approved targeted therapy for tumors with any KRAS mutation, according to the press release.
Sororasib (Lumakras, Amgen) was granted priority review in mid-February and has previously shown clinical benefit in KRAS G12C-mutated NSCLC.
“KRAS mutations have long been considered resistant to drug therapy, representing a true unmet need for patients with certain types of cancer,” 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, said in the release. “Today’s approval represents a significant step towards a future where more patients will have a personalized treatment approach.”
The most common adverse side effects of the drug are nausea, fatigue, hepatotoxicity, cough, diarrhea and musculoskeletal pain.
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FDA. FDA Approved Drugs. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214665. Accessed May 28, 2021.
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