FDA approves adagrasib for certain adults with non-small cell lung cancer
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The FDA granted accelerated approval to adagrasib for certain adults with non-small cell lung cancer.
The indication applies to use of adagrasib (Krazati, Mirati Therapeutics) — a RAS GTPase family inhibitor — by adults with KRASG12C-mutated locally advanced or metastatic NSCLC who received at least one prior systemic therapy.
The FDA also approved the therascreen KRAS RGQ PCR kit (Qiagen) and the ctDx FIRST assay (Agilent Technologies) as companion diagnostics, the former to test tissue specimens and the latter to test plasma specimens.
The agency based the adagrasib approval on results of the multicenter, single-arm KRYSTAL-1 trial. Researchers evaluated the efficacy of adagrasib among 112 patients with locally advanced or metastatic NSCLC and KRASG12C mutations whose disease progressed on or after platinum-based chemotherapy and an immune checkpoint inhibitor.
Trial participants received 600 mg adagrasib orally twice daily until disease progression or unacceptable toxicity.
Researchers reported an objective response rate of 43% (95% CI, 34-53) and a median response duration of 8.5 months (95% CI, 6.2-13.8).
Adverse reactions that occurred among at least 20% of adagrasib-treated patients included diarrhea, nausea, fatigue, vomiting, musculoskeletal pain, hepatotoxicity, renal impairment, dyspnea, edema, decreased appetite, cough, pneumonia, dizziness, constipation, abdominal pain and QTc interval prolongation.
Laboratory abnormalities that occurred among at least 25% of patients included decreased lymphocytes, increased aspartate aminotransferase, decreased sodium, decreased hemoglobin, increased creatinine, decreased albumin, increased alanine aminotransferase, increased lipase, decreased platelets, decreased magnesium and decreased potassium.
The FDA previously granted fast track, breakthrough therapy and orphan drug designations to this application.
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