Merck KGaA’s Tepmetko (tepotinib) Receives the US FDA’s Approval for Patients with Metastatic NSCLC with METex14 Skipping Alterations

February 4, 2021 Auto Bot approval, FDA, Merck KGaA, patients, receives, regulatory 0

Shots:

  • The approval is based on pivotal P- II VISION study that involves assessing of Tepmetko (450mg, qd) as monothx. in 152 patients with a median age of 73 years with advanced/ m-NSCLC with METex14 skipping alterations
  • Results: treatment-naïve patients & previously treated patients, ORR (43% & 43%); mDoR (0.8 and 11.1mos.); DoR @6mos. (67% & 75%); DoR @9mos. (30% & 50%) respectively
  • Tepmetko is an oral MET inhibitor that inhibits the oncogenic MET receptor signaling caused by MET (gene) alterations and approved for both treatment naïve and previously treated METex14 positive NSCLC patients

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Business Insider

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