Bayer’s Vitrakvi Receives MHLW’s Approval for the Treatment of NTRK Fusion-Positive Advanced or Recurrent Solid Tumors

March 24, 2021 Auto Bot Bayer, Marketing Authorization, MHLW, receives, Recurrent, regulatory, Solid Tumors, Treatment 0

Shots:

  • The approval is based on the P-III NAVIGATE trial in adult and adolescent patients and P- I/II pediatric SCOUT trial involves assessing Vitrakvi for NTRK fusion-positive advanced or recurrent solid tumors
  • The P-III NAVIGATE trial showed ORR (65.2%), CR (16.9%), and P-I/II SCOUT trial showed ORR (88.9%), CR (22.2%). In general, the studies demonstrated high response rates, durable responses, and a favorable safety profile in adults and children with TRK fusion cancer
  • The approval follows the approval of the expanded use of FoundationOne CDx in Japan for use as a CDx to identify patients with TRK fusion cancer who are expected to benefit from treatment with Vitrakvi

Click here ­to­ read full press release/ article | Ref: Bayer | Image: Industry Week

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