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AmoyDx will develop and seek regulatory approval in China for a lung cancer PCR panel to be used with Merck's MET inhibitor tepotinib.
The agency granted the NDA priority review, putting the application on a six-month review clock, instead of the 10-month standard review time frame.
AmoyDx aims to develop a companion diagnostic for Merck KGaA's non-small cell lung cancer treatment Tepmetko, which was recently approved in Japan.
The drug, tepotinib, will now be available to treat advanced non-small cell lung cancer patients in Japan with MET exon 14 skipping alterations.
The German drugmaker plans to advance the NSCLC treatment in parallel with tissue-based and liquid biopsy companion assays that can identify best responders.