Shots:

• The MAA is submission is based on P-I trial of adult patients- P-II NAVIGATE study in adult and adolescent patients and the P-I/II pediatric SCOUT study. These trials evaluate larotrectinib in 20+ histologies of solid tumors including lung- thyroid- melanoma- gastrointestinal stromal tumors- colon- cholangiocarcinoma- soft tissue sarcomas- salivary gland and infantile fibrosarcoma
• The therapy is already approved in multiple countries including the US- Brazil- Canada and countries of EU- under the brand name Vitrakvi while the filings in other region are in progress
• Larotrectinib is an oral TRK inhibitor- intended to treat adults and children with LA/ m-solid tumors with NTRK gene fusion. Following the acquisition of Loxo by Eli Lilly and Company in Feb’ 2019- Bayer has obtained the exclusive licensing rights for larotrectinib and the selitrectinib (BAY 2731954) which is under clinical development

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