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FDA Grants Full Approval to Merck KGaA's Tepmetko in Advanced METex14-Altered NSCLC

NEW YORK – The US Food and Drug Administration on Thursday converted a prior accelerated approval for Merck KGaA's Tepmetko (tepotinib) to full approval as a treatment for metastatic non-small cell lung cancer patients with MET exon 14 skipping alterations.

The FDA had granted accelerated approval to the kinase inhibitor based on initial overall response and duration of response data from the Phase II VISION trial. Now, the full approval is supported by additional data from 161 patients and 28 more months of follow-up.

In total, 313 patients in the trial received Tepmetko. Of 164 patients who received the drug in the first-line setting, the overall response rate was 57 percent, and 40 percent of these responses lasted more than a year. Among the149 patients who received the drug in later-line settings, the overall response rate was 45 percent, and 36 percent of these responses lasted more than a year.

Darmstadt, Germany-based Merck's drug is approved in Europe for previously treated NSCLC patients with MET exon 14 skipping alterations and in Japan for metastatic NSCLC patients with such alterations as determined by Amoy Diagnostics' AmoyDx PLC Panel. In 2022, the UK's National Institute for Health and Care Excellence (NICE) also recommended Tepmetko for this subset of advanced NSCLC patients.