Loxo’s Vitrakvi (larotrectinib) Receives the US FDA Approval for the Treatment of Solid Tumors in Adults and Pediatric Patients

 Loxo’s Vitrakvi (larotrectinib) Receives the US FDA Approval for the Treatment of Solid Tumors in Adults and Pediatric Patients

Loxo’s Vitrakvi (larotrectinib) Receives the US FDA Approval for the Treatment of Solid Tumors in Adults and Pediatric Patients

Shots:

  • The approval is based on combined data from P-I adult trial, P-II NAVIGATE trial and P-I/II pediatric SCOUT trial assessing Vitrakvi in solid tumors with neurotrophic receptor tyrosine kinase (NTRK) gene fusion
  • Pooled results: ORR 75%; CR 22%; PR 53%; DOR 73%; median time of response 1.84 mos., presented at ESMO 2018
  • Vitrakvi is an oral oncogenic driver of TRK inhibitor, received FDA’s Breakthrough Therapy & Rare Pediatric Disease and Orphan Drug designation, jointly developed by Bayer and Loxo since 2017

Click here to read full press release/ article | Ref: Loxo Oncology | Image: Stamford