Bayer Reports Submission of MAA to the MHLW for Larotrectinib to Treat Solid Tumors with NTRK Gene Fusion

Bayer Reports Submission of MAA to the MHLW for Larotrectinib to Treat Solid Tumors with TRK Fusion

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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