Swiss pharmaceutical giant Roche announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its tumor-agnostic therapy Rozlytrek (entrectinib). The drug is approved for treating solid tumors in patients aged 12 and older who carry a neurotrophic tyrosine receptor kinase (NTRK) fusion gene and have locally advanced, metastatic disease, or surgical resection that may lead to serious complications, with no satisfactory replacement or prior therapy failure.
Drug Profile
Entrectinib is a potent and selective inhibitor targeting pan-TRK and ROS1 tyrosine kinases with central nervous system (CNS) activities. It can cross the blood-brain barrier and has been approved to treat patients with NTRK fusion gene-positive solid tumors and ROS1-positive advanced non-small cell lung cancer since 2019 in Japan, the United States, and Europe.
Efficacy Data
The STARTRK-2 study (NCT02568267) showed that, as assessed by the Blinded Independent Central Review (BICR), the systemic objective response rate (ORR) of patients with positive NTRK fusion gene reached 81%, while the intracranial ORR was 100%, and the median progression-free survival (PFS) was 30.3 months.
Market Context
TRK inhibitors are rarely accessible and used in clinics in China, leaving a significant unmet medical need. Entrectinib demonstrates consistent clinical benefits in the Chinese population, both systemically and intracranially. Bayer’s Vitrakvi (larotrectinib) was approved in China in April 2022 to treat all cancers.-Fineline Info & Tech
