The Center for Drug Evaluation (CDE) website has indicated that Roche’s (SWX: ROG) Rozlytrek (entrectinib) is likely to receive priority review status for the treatment of children with NTRK fusion positive locally advanced or metastatic solid tumors. This priority review status is justified by the drug’s eligibility for conditional approval.
Entrectinib’s TRK/ROS1 Targeted Inhibition and CNS Activity
Entrectinib is a TRK/ROS1 targeted inhibitor known for its central nervous system (CNS) activities and its ability to cross the blood-brain barrier. Since its commercial availability began in 2019, the drug has been used in Japan, the US, and Europe to treat patients with NTRK fusion gene positive solid tumors and ROS1 positive advanced non-small cell lung cancer (NSCLC).
Market Approval History and Expansion in China
Rozlytrek obtained its first market approval in China in July 2022, following Bayer’s Vitrakvi (larotrectinib) as the second NTRK inhibitor to enter the Chinese market. The drug further expanded its indications in China, gaining a second approval one month later to treat ROS1 positive locally advanced or metastatic non-small cell lung cancer (NSCLC).-Fineline Info & Tech
