(Lung Cancer) FDA Grants Accelerated Approval to Lumakras

• June 25, 2021
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On May 28, 2021, the FDA granted accelerated approval to Lumakras (sotorasib), a RAS GTPase family inhibitor, for previously treated patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutation. The approval also simultaneously authorized two companion diagnostics: QIAGEN's therascreen® KRAS RGQ PCR Kit for tumor tissue testing, and Guardant Health's Guardant360® CDx liquid biopsy for plasma testing.

The approval was based on the CodeBreaK 100 trial (NCT03600883) — a multicenter, single-arm, open-label clinical trial enrolling 124 previously treated patients with locally advanced or metastatic NSCLC harboring KRAS G12C mutations. Patients received Lumakras 960 mg orally once daily until disease progression or unacceptable toxicity.

Primary endpoints: Objective response rate (ORR) and duration of response (DOR).

• ORR: 36%
• Median DOR: 10 months

Most common adverse events (incidence ≥20%): Diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity, and cough. Most common laboratory abnormalities included lymphocytopenia, decreased hemoglobin, AST elevation, ALT elevation, decreased calcium, ALP elevation, increased urine protein, and decreased sodium.

Recommended dose: 960 mg orally once daily, with or without food.

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sotorasib-kras-g12c-mutated-nsclc

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