Sandra Horning, MD
Entrectinib (Rozlytrek) received its first regulatory approval, as Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved the drug for the treatment of adult and pediatric patients with NTRK
fusion–positive, advanced recurrent solid tumors.
The MHLW based its decision on data from the phase II STARTRK-2, phase I STARTRK-1, and phase I ALKA-372-001 trials, as well as findings from the phase I/II STARTRK-NG pediatric study. In STARTRK-2, specifically, entrectinib achieved an objective response rate (ORR) of 56.9% in patients with NTRK-positive solid tumors.1
The median duration of response was 10.4 months. Among patients with CNS metastases, the intracranial ORR (IC ORR) was 50%.