Shots:

• The approval is based on integrated analysis including data from 74 people with LA/ m-NTRK fusion-positive solid tumors (14 tumor types) & 161 people with ROS1+ NSCLC of the pivotal P-II STARTRK-2- P-I STARTRK-1 and P-I ALKA-372-001 trials- and data from the P-I/II STARTRK-NG study in pediatric patients
• Result: in NTRK fusion+ solid tumors- ORR (63.5%); mDoR (12.9mos.); In ROS1+ advanced NSCLC- shrank tumors in 73.4% of patients; DoR of 16.5mos. (14.6-28.6mos.); ORR (67.1%); in patients with CNS metastases with an intracranial ORR (62.5% & 77.8%); In pediatric patients- Rozlytrek shrank tumors in all children and adolescents who had NTRK gene fusions with two achieving a CR
• Rozlytrek (entrectinib- qd) is a tumor-agnostic treatment for LA/m-solid tumors harboring NTRK1/2/3 or ROS1 gene fusions and has received EMA’s PRIME designation to treat NTRK fusion-positive- LA/m- solid tumors in adult and pediatric patients who have either progressed following prior therapies or who have no acceptable standard therapies

­ Ref: Roche | Image: Roche