FDA grants accelerated approval to Tepmetko for metastatic NSCLC

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FDA has granted accelerated approval to Tepmetko (tepotinib) for adult patients with metastatic non-small cell lung cancer harboring mesenchymal-epithelial transition exon 14 skipping alterations.

Tepmetko is sponsored by EMD Serono Inc.

Efficacy was demonstrated in the VISION trial (NCT02864992), a multicenter, non-randomized, open-label, multicohort study enrolling 152 patients with advanced or metastatic NSCLC with MET exon 14 skipping alterations. Patients received tepotinib 450 mg orally once daily until disease progression or unacceptable toxicity.

The main efficacy outcome measures were overall response rate determined by a blinded independent review committee using RECIST 1.1 and response duration. Among the 69 treatment naïve patients, the ORR was 43% (95% CI: 32%, 56%) with a median response duration of 10.8 months (95% CI: 6.9, not estimable). Among the 83 previously treated patients, the ORR was 43% (95% CI: 33%, 55%) with a median response duration of 11.1 months (95% CI: 9.5, 18.5).

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