NMPA (China) approves Vitrakvi to treat advanced solid tumors that harbour a NTRK gene fusion. Bayer

NTRK gene fusions should be identified by a sufficiently validated test.

Larotrectinib is a first-in-class, highly selective TRK inhibitor exclusively designed to treat solid tumors that have an NTRK gene fusion, also known as TRK fusion solid tumors. This precision oncology treatment has demonstrated high response rates, durable responses and a favorable safety profile in adults and children with TRK fusion solid tumors. Vitrakvi is already approved in the U.S., Japan, countries of the European Union (EU), the UK and other markets around the world.

The approval of larotrectinib in China is based on data from the Phase I trial of adult patients, the Phase II NAVIGATE trial in adult and adolescent patients and the Phase I/II pediatric SCOUT trial. In these trials, larotrectinib was investigated across more than 20 different histologies of solid tumors including lung cancer, thyroid cancer and colorectal cancer as well as salivary gland cancer and soft tissue sarcomas including infantile fibrosarcoma and gastrointestinal stromal tumors. The compound has shown powerful efficacy with high response rates and durable responses as well as a favorable safety profile across tumor types in adults and children with TRK fusion solid tumors. The clinical activity has been shown across multiple tumor types including primary central nervous system (CNS) tumors and brain metastases..