Shots:

• The NDA submission is based on P-I study of adult patients- the P-II NAVIGATE trial in adult and adolescent patients and the P- I/II pediatric SCOUT trial. These trials evaluated Larotrectinib in 20+ different histologies of solid tumors with NTRK fusion
• The therapy is already approved in several countries under the brand name Vitrakvi- including the US- EU- and Japan. The regulatory filing in other countries are underway or planned
• Larotrectinib is a highly selective TRK inhibitor exclusively designed to treat tumors that have an NTRK gene fusion

  Ref: Bayer | Image: Shanghai Daily