Bayer’s Vitrakvi (larotrectinib) Receives EMA’s Approval as the First Tumor Agonist in Europe

Bayer’s Vitrakvi (larotrectinib) Receives EMA’s Approval as the First Tumor Agonist in Europe

Shots:

  • The approval is based on the pooled clinical study including P-I study in adults, P-II NAVIGATE study in adults & adolescents & P-I/II pediatric SCOUT study assessing Vitrakvi in 102 patients (93 patients from the primary analysis population and an additional 9 patients with primary CNS tumors) with solid tumors displaying NTRK gene
  • Results: primary analysis population, ORR (72%); CR (16%); PR (55%); Post 1yr. 88% patients were alive; primary CNS patients, ORR (67%); CR & PR (15% & 15%); neither mDOR nor mPFS met at the time of analysis
  • Vitrakvi is an oral highly selective TRK inhibitor, already approved in the US, Brazil & Canada. Following LOXO acquisition, Bayer got WW exclusive licensing right to develop & commercialize larotrectinib and the investigational TRK inhibitor BAY 2731954

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