FDA grants priority review for tepotinib for the treatment of metastatic NSCLC with tumors with a mutation that leads to mesenchymal-epithelial transition exon 14 (METex14) skipping.- Merck KGaA

Merck KGaA, announced that the FDA has accepted and granted Priority Review to the new drug application (NDA) for once-daily, orally-dosed tepotinib for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition exon 14 (METex14) skipping, as detected by an FDA-approved test. Tepotinib was granted Priority Review and is being reviewed by the FDA under its Real-Time Oncology Review (RTOR) pilot program, which is intended to create a more efficient review process to bring safe and effective treatments to patients as early as possible. Priority Review is intended to accelerate evaluation of applications for drugs that could offer improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. Tepotinib was granted Breakthrough Therapy Designation by the FDA in September 2019 for the treatment of patients with metastatic NSCLC harbouring METex14 skipping alterations who progressed following platinum-based cancer therapy. The application is based on results from the pivotal ongoing, single-arm Phase II VISION study (NCT02864992) evaluating tepotinib as monotherapy in patients with advanced NSCLC with MET exon 14 (METex14) skipping alterations prospectively assessed by liquid and/or tissue biopsy. Results demonstrate consistent response rate and durable anti-tumor activity across lines of treatment including in patients with brain metastases and in patients assessed by both liquid biopsy (LBx) and tissue biopsy (TBx). Data from the primary analysis of the VISION study were published in The New England Journal of Medicine (NEJM) on May 29, 2020 and presented during the American Society of Clinical Oncology (ASCO) ASCO20 Virtual Scientific Program. See- "Tepotinib in Non–Small-Cell Lung Cancer with MET Exon 14 Skipping Mutations." Paul K. Paik, M.D., Enriqueta Felip, M.D., Ph.D., Remi Veillon, M.D., Hiroshi Sakai, M.D., et al.-May 29, 2020 DOI: 10.1056/NEJMoa2004407.