Posted by Michael Wonder on 25 Aug 2020
FDA accepts filing of new drug application for tepotinib for the treatment of patients with metastatic NSCLC with METex14 skipping alterations
25 August 2020 - Tepotinib granted priority review and is being evaluated under FDA Real-Time Oncology Review pilot program.
Merck, a leading science and technology company, today announced that the US FDA has accepted and granted priority review to the new drug application for once-daily, orally-dosed tepotinib for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a mutation that leads to mesenchymal-epithelial transition exon 14 skipping, as detected by an FDA approved test.
The application is based on results from the pivotal ongoing, single-arm Phase II VISION trial evaluating tepotinib as monotherapy in patients with advanced NSCLC with MET exon 14 skipping alterations prospectively assessed by liquid and/or tissue biopsy.
