Swiss pharmaceutical giant Roche (SWX: ROG) has received a new indication approval from the National Medical Products Administration (NMPA) for its drug Rozlytrek (entrectinib). The approval allows the treatment of pediatric patients aged at least one month with NTRK fusion-positive solid tumors.
Entrectinib is a TRK/ROS1 tyrosine kinase inhibitor known for its ability to cross the blood-brain barrier, demonstrating significant central nervous system (CNS) activity. Results from the Phase I/II STARTRK-NG study indicated that the drug achieved rapid and sustained remission, along with a consistent safety profile in children and adolescents suffering from extracranial solid tumors or primary CNS tumors harboring NTRK1/2/3, ROS1, or ALK fusion genes.
Since its initial approval in 2019, entrectinib has been commercially available for treating NTRK fusion-positive solid tumors and ROS1-positive advanced non-small cell lung cancer (NSCLC) patients in Japan, the US, and the EU. In China, the drug was first approved for NTRK fusion-positive solid tumors in patients aged 12 and above in July 2022, followed by ROS1-positive NSCLC approval a month later. Both indications are included in the National Reimbursement Drug List (NRDL).- Flcube.com
