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FDA Approves Tepotinib for Patients With Metastatic Non-Small Cell Lung Cancer Harboring MET Exon 14 Skipping Alterations
On February 15, 2024, the US Food and Drug Administration (FDA) approved tepotinib for patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. This regulatory decision was based on updated results from the phase 2 VISION trial, and amends the accelerated approval previously granted for patients with metastatic NSCLC harboring MET exon 14 skipping alterations.
In this open-label, nonrandomized study, 313 patients with either treatment-naïve (n = 164) or previously treated (n = 149) metastatic NSCLC harboring MET exon 14 skipping alterations received 450 mg once daily of tepotinib until disease progression or unacceptable toxicity. The primary efficacy measures were objective response rate (ORR) and duration of response (DOR), determined by Blinded Independent Review Committee.
At a follow-up of 28 months, ORR was 57%, with 40% of responders having a DOR ≥12 months, in the treatment-naïve arm. In the previously treated arm, ORR was 45%, with 36% of responders having a DOR ≥12 months. The most common adverse events occurring in ≥20% of patients included edema, nausea, fatigue, musculoskeletal pain, diarrhea, dyspnea, decreased appetite, and rash.
The recommended dose of tepotinib is 450 mg orally once daily with food until disease progression or unacceptable toxicity.
Source:
FDA approves tepotinib for metastatic non-small cell lung cancer. Published February 16, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tepotinib-metastatic-non-small-cell-lung-cancer
