NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use on Friday issued a positive opinion recommending tepotinib (Merck KGaA/EMD Serono's Tepmetko) for previously treated, advanced non-small cell lung cancer patients with MET exon 14 skipping alterations.
CHMP's recommendation is specifically for advanced NSCLC patients with these alterations who require systemic therapy after receiving immunotherapy or platinum-based chemotherapy. The European Commission will review CHMP's opinion and decide in the first quarter of 2022 whether to grant patients access to the treatment in this setting.
The committee recommended tepotinib after reviewing data from the VISION trial, which enrolled treatment naïve and previously treated patients. The overall response rate was 43 percent, and the duration of response was 10.8 months in those who had not received prior treatment. The overall response rate was also 43 percent, and duration of response was 11.1 months among previously treated patients.
Aberrations in the MET pathway, including MET exon 14 skipping alterations, characterize up to 4 percent of NSCLC tumors. The US Food and Drug Administration earlier this year used the same data from the VISION study to grant accelerated approval to tepotinib for metastatic NSCLC patients with MET exon 14 skipping alterations, regardless of whether they were previously treated or not.