Entrectinib (Rozlytrek) has been granted marketing approval by Japan’s Ministry of Health, Labour and Welfare (MHLW) for the treatment of adult and paediatric patients with neurotrophic tyrosine receptor kinase (NTRK) fusion-positive, advanced recurrent solid tumours.
Entrectinib is the first tumour-agnostic medicine to be approved in Japan that targets NTRK gene fusions, which have been identified in a range of hard-to-treat solid tumour types, including pancreatic, thyroid, salivary gland, breast, colorectal, and lung. It has been granted Sakigake designation and orphan drug designation by the MHLW, Roche said.
Entrectinib 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).
The data package for this first approval of entrectinib includes the pivotal phase II STARTRK-2, phase I STARTRK-1 and phase I ALKA-372-001 trials, as well as data from the phase I/II STARTRK-NG study in paediatric patients.
In the pivotal phase II STARTRK-2 study, entrectinib shrank tumours in more than half of people with NTRK fusion-positive solid tumours. Objective responses to entrectinib were seen across 10 different solid tumour types, including in people with and without CNS metastases at baseline.
The drug also shrank tumours that had spread to the brain in more than half of people