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Tepotinib May Now Be Used to Treat Patients with METex14+ NSCLC, FDA Says

Accelerated approval was granted to the highly selective MET inhibitor tepotinib (Tepmetko) for the treatment of adults with metastatic non–small cell lung cancer (NSCLC) and MET exon 14 skipping alterations.1

Results of the phase 2 study VISION study (NCT02864992) served as the basis of the approval and were published in the New England Journal of Medicine in 2020.2

On the trial, patients received 500 mg of tepotinib once daily with a primary outcome of objective response rate (ORR) by independent review among patients with at least 9 months of follow-up. Additionally, response was analyzed according to whether the presence of a MET exon 14 skipping mutation was detected on liquid or tissue biopsy.

The ORR by independent review was 46% (95% CI, 36%-57%), with a median duration of response (DOR) of 11.1 months (95% CI, 7.2-notestimable [NE]) in the combined-biopsy group. ORRs in…

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