Tepotinib approved for NSCLC with MET exon 14 mutations
medwireNews: The MET inhibitor tepotinib has received accelerated approval from the US FDA for the treatment of metastatic non-small-cell lung cancer (NSCLC) harboring MET exon 14 skipping mutations.
The decision is based on the phase 2 VISION trial that showed an overall response rate of 43% in both the treatment-naïve and previously treated subgroups. The median response durations were 10.8 and 11.1 months, respectively.
The press release specifies, however, that “[c]ontinued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.”
Tepotinib is to be taken orally and with food at a daily dose of 450 mg until disease progression or unacceptable toxicity.
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