InnoCare Pharma's Zurletrectinib approved in China for solid tumors

The National Medical Products Administration (NMPA) has approved InnoCare Pharma's zurletrectinib (ICP-723) for treating adult and adolescent patients (aged 12 years and older) with solid tumors harboring NTRK gene fusions in China. This approval marks a significant advancement in the treatment landscape for these patients.

In clinical trials, zurletrectinib demonstrated an objective response rate (ORR) of 89.1% and a disease control rate (DCR) of 96.4%. The 24-month progression-free survival (PFS) and overall survival (OS) rates were 77.4% and 90.8%, respectively. The company also plans to submit a new drug application (NDA) for zurletrectinib to treat pediatric patients (aged 2 to 12) soon.

NTRK fusion genes are present in over 26 types of solid tumors, with approximately 6,500 new cases estimated annually in China. Zurletrectinib, administered as a once-daily oral two-tablet dose, has shown superior efficacy compared to first-generation TRK inhibitors, delivering durable deep remissions, strong brain penetration, and overcoming acquired resistance.