News
CHMP positive opinion for once-daily oral Tepmetko to treat NSCLC with MET exon 14 skipping mutations.- Merck KGaA.
Merck KGaA,has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of once-daily oral Tepmetko (tepotinib) as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.
The CHMP positive opinion will now be reviewed by the European Commission (EC), with a decision expected in the first quarter of 2022.
Condition: NSCLC / MET
Type: drug