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# EMD Serono NDA for Lung Cancer
- URL: https://www.fdaweb.com/emd-serono-nda-for-lung-cancer/
- Published: 2020-08-26T12:00:00.000Z
- Updated: 2026-09-14T16:26:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147519

FDA has accepted for priority review an EMD Serono NDA for once-daily, orally-dosed tepotinib for treating 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. Alterations of the METex14 signaling pathway are found in various cancer types, including 3% to 5% of NSCLC cases, and lead to aggressive tumor behavior and poor clinical prognosis, EMD says. The submission is being reviewed under the agency’s Real-Time Oncology Review pilot program.

The NDA is based on results from the pivotal ongoing, single-arm Phase 2 VISION study evaluating tepotinib as monotherapy in patients with advanced NSCLC with the mutation skipping alterations. “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 and tissue biopsy,**”** the company says.