Lumakras (sotorasib) received the first approval for a targeted therapy in adults with non-small cell lung cancer with KRAS G12C genetic mutations, the U.S. Food and Drug Administration announced on May 28.
KRAS G12C mutations make up about 13 percent of mutations in non-small cell lung cancers. The FDA approved the 960-mg dose of Lumakras based on clinical data and pharmacokinetic and pharmacodynamic modeling to support the approved dose.
The approval of Lumakras was also based on efficacy data from a subset of 124 patients in CodeBreak 100. Patients had locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer, and their disease progressed after treatment with an immune checkpoint inhibitor or platinum-based chemotherapy. The researchers found an objective response rate of 36 percent with Lumakras, and 58 percent of patients who responded had a response duration of six months or longer. Eighty-one percent of patients achieved disease control, defined as complete response, partial response, or stable disease for more than three months.
The most commonly reported side effects were diarrhea, musculoskeletal pain, nausea, fatigue, liver damage, and cough. The FDA notes that Lumakras should be withheld if a patient develops symptoms of interstitial lung disease. Clinicians are advised to monitor patients’ liver function tests before starting Lumakras and during Lumakras administration.
Approval was granted to Amgen. The FDA is requiring a postmarketing trial to investigate if a lower dose of Lumakras will yield a similar clinical effect.
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