Repotrectinib has the potential to become a next-generation TKI that can be used across a broad range of NTRK fusion-positive solid tumors in both settings. In June 2024, AUGTYRO (repotrectinib ...

The indication is specifically for those patients who have solid tumors with a neurotrophic receptor tyrosine kinase (NTRK) gene fusion that are without a known acquired resistance mutation, are ...

1 VITRAKVI has demonstrated clinically meaningful and durable responses across a range of NTRK fusion-positive solid tumors. VITRAKVI was first granted accelerated approval by FDA in November 2018.

Vitrakvi received full FDA approval for treating NTRK gene fusion-positive solid tumors in adults and children, following its initial accelerated approval in 2018. The drug functions as a tyrosine ...

SHANGHAI & CAMBRIDGE, Mass., April 21, 2025--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that China’s National Medical Products Administration (NMPA) has accepted ...

VITRAKVI ® is now fully approved for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance ...

In February 2025, China’s NMPA granted priority review to repotrectinib for the treatment of adult patients with advanced solid tumors that have an NTRK gene fusion. In June 2024, AUGTYRO ...

for repotrectinib for the treatment of adult patients with solid tumors that harbor a neurotrophic tyrosine receptor kinase ( NTRK) gene fusion. The application is intended for patients whose ...

"NTRK fusion-positive tumors represent a significant therapeutic challenge, particularly in the setting of acquired resistance to existing TRK tyrosine kinase inhibitors (TKIs)," said Dr. Rafael Amado ...