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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.

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