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FDA Accepts EMD Serono's Tepotinib Application for METex14 Advanced NSCLC

NEW YORK – The US Food and Drug Administration has accepted EMD Serono's new drug application for tepotinib as a treatment for metastatic non-small cell lung cancer with a MET exon 14 skipping mutation.

EMD Serono, a subsidiary of Merck KGaA, announced on Tuesday that the agency had also granted its NDA priority review, putting the application on a six-month review clock, instead of the 10-month standard review time frame.

The company submitted data from the Phase II VISION study, in which nearly 100 advanced NSCLC patients with MET exon 14 skipping mutations received tepotinib. Patients had their mutation status determined prospectively based on genomic analysis of liquid and tumor tissue samples. The objective response rate was 42.4 percent and the median duration of response was more than a year. The drug was well tolerated, though 11 patients discontinued treatment due to adverse events.

Based on this same data, the Japanese Ministry of Health, Labor, and Welfare in March approved tepotinib (under the brand name Tepmetko) for advanced NSCLC with MET exon 14 skipping alterations. The agency at the time also approved ArcherDX's ArcherMET test as a companion diagnostic to identify MET exon 14 skipping alterations in patients' tissue and liquid biopsy samples and identify those eligible for tepotinib treatment. These mutations occur in between 3 percent and 5 percent of NSCLC patients. 

"METex14 skipping alterations drive a particularly aggressive form of NSCLC in a patient population that is generally elderly, facing poor clinical prognosis and in urgent need of new therapeutic options," Luciano Rossetti, global head of R&D at EMD Serono, said in a statement. "With this acceptance and review under the Real-Time Oncology Review program, we look forward to working with FDA and to making this precision medicine available to patients in the US as soon as possible."