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
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