Merck KGaA’s Tepmetko (tepotinib) Receives the Japanese MHLW’s Approval for Advanced NSCLC with METex14 Skipping Alterations

Merck KGaA’s Tepmetko (tepotinib) Receives the MHLW’s Approval for Advanced NSCLC with METex14 Skipping Alterations

Shots:

  • The approval is based on ongoing P-II VISION study assessing Tepmetko in 99 patients (including 15 Japanese patients) with NSCLC and METex14 skipping alterations  
  • The P-II VISION study results: ORR as assessed by IRC (42.4%) in patients identified by LBx/ TBx; mDOR (12.4mos) for both LBx/TBx identified. Additionally, in the safety analysis of 130 patients, Tepmetko was well tolerated
  • Tepmetko (500mg, qd) is an oral MET inhibitor in Japan to be approved for the line-agnostic treatment of advanced NSCLC with MET exon 14 (METex14) skipping alterations and has received FDA’s BT designation in Sept’2019 with its anticipated regulatory filing to the US FDA  in 2020

Click here ­to­ read full press release/ article | Ref: Merck KGaA | Image: GMP News