(RTTNews) - Merck KGaA (MKGAY.PK) announced the CHMP of the European Medicines Agency adopted a positive opinion recommending approval of once-daily oral TEPMETKO as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer harboring alterations leading to mesenchymal-epithelial transition factor gene exon 14 skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. The decision by European Commission is expected in the first quarter of 2022.
In February 2021, the U.S. FDA granted accelerated approval to TEPMETKO, making it the first and only once-daily oral MET inhibitor approved for patients in the U.S. with metastatic NSCLC with METex14 skipping alterations.
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