Savolitinib Supplemental NDA Accepted in China for Treatment-Naïve or Previously Treated Patients with Locally Advanced or Metastatic MET Exon 14 NSCLC

“sNDA for savolitinib, in adult patients with locally advanced or metastatic non-small cell lung cancer with MET exon 14 skipping alteration, has been accepted for review by the China National Medical Products Administration (NMPA). If approved, the new label indication for savolitinib will be expanded to include treatment-naive patients in China.”

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