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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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