FDA Approves First Targeted Therapy for Subset of Non-Small Cell Lung Cancer


The agency approved Lumakras, the first targeted therapy for patients with non-small cell lung cancer and a KRAS G12C mutation, whose disease progressed after one systemic therapy.

The Food and Drug Administration (FDA) approved the targeted therapy Lumakras (sotorasib) for adult patients with non-small cell lung cancer with a KRAS G12C mutation who were previously treated with at least one systemic therapy.

Patients with any KRAS mutation accounts for 25% of mutations in non-small cell lung cancers, and KRAS G12C mutations account for an estimated 13% of mutations in non-small cell lung cancers, according to an FDA release. KRAS is a type of mutation in genes that regulate cell division and growth.

“KRAS mutations have long been considered resistant to drug therapy, representing a true unmet need for patients with certain types of cancer,” said Dr. Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Disease in the FDA’s Center for Drug Evaluation and Research, in the release. “Today’s approval represents a significant step toward a future where more patients will have a personalized treatment approach.”

The efficacy of Lumakras was assessed in a study with 124 patients with locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer whose disease progressed after receiving platinum-based chemotherapy and/or an immune checkpoint inhibitor. The objective response rate (defined as the proportion of patients whose tumor was reduced or destroyed) was 36%, of whom 58% had a duration of response of at least six months.

The FDA approved a 960-milligram dose of Lumakras based on available clinical data and modeling that support this approved dose, according to the release. A post-marketing trial is required by the FDA to assess whether a lower dose of Lumakras will have a similar effect on patients.

The most common side effects with Lumakras include musculoskeletal pain, diarrhea, fatigue, nausea, cough and liver damage, according to the release. The drug should be withheld if patients develop symptoms of interstitial lung disease and discontinued permanently if the disease if confirmed. A patient’s liver function should be monitored before and during treatment with Lumakras. The treatment should be withheld, dose reduced or permanently discontinued if a patient develops liver damage. While taking Lumakras, patients should avoid taking acid-reducing agents.

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Image of Dr. Minesh Mehta at ASCO 2024.