Roche has announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Rozlytrek (entrectinib) for the treatment of adult and pediatric patients with neurotrophic tyrosine receptor kinase (NTRK) fusion-positive, advanced recurrent solid tumors. Rozlytrek is the first tumor-agnostic medicine to be approved in Japan that targets NTRK gene fusions, which have been identified in a range of hard-to-treat solid tumor types, including pancreatic, thyroid, salivary gland, breast, colorectal, and lung. It has been granted Sakigake designation and orphan drug designation by the MHLW.
Rozlytrek is also undergoing regulatory review in Japan for the treatment of people with ROS1 fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).
Results showed:
• In the pivotal Phase II STARTRK-2 study, Rozlytrek shrank tumors in more than half of people with NTRK fusion-positive solid tumors. Objective responses to Rozlytrek were seen across 10 different solid tumor types (median duration of response [DoR] = 10.4 months), including in people with and without CNS metastases at baseline. Importantly, Rozlytrek also shrank tumors that had spread to the brain in more than half of people (intracranial response [IC] ORR = 50.0 percent).
• Biomarker testing for NTRK gene fusions is the only way to identify people who may be eligible for treatment with Rozlytrek.
• Rozlytrek has been granted Priority Review by the FDA for the treatment of NTRK fusion-positive, locally advanced or metastatic solid tumors in adult and pediatric patients who have either progressed following prior therapies or as an initial therapy when there are no acceptable standard therapies, and for the treatment of people with metastatic, ROS1 fusion-positive NSCLC. It has also been granted Priority Medicines (PRIME) designation by the European Medicines Agency (EMA) and Sakigake designation and orphan drug designation by MHLW.
