Japan becomes the first country to approve Roche’s personalised medicine Rozlytrek

First tumour-agnostic medicine approved in Japan for adult and paediatric patients with NTRK fusion-positive advanced recurrent solid tumours Approval supported by the data mainly from the pivotal Phase II STARTRK-2 study showing that Rozlytrek shrank tumours in more than half of people with NTRK fusion-positive solid tumours, across 10 different tumour types, including those with central nervous system metastases Rozlytrek is also undergoing review in Japan for the treatment of ROS1 fusion-positive non-small cell lung cancer Roche today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Rozlytrek (entrectinib) for the treatment of adult and paediatric patients with neurotrophic tyrosine receptor kinase (NTRK) fusion-positive, advanced recurrent solid tumours. Rozlytrek 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.¹ It has been granted Sakigake designation and orphan drug designation by the MHLW.² 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).² "Today's approval of Rozlytrek represents a new chapter in personalised healthcare, applying advanced diagnostics to deliver precision medicines that target cancers based on their molecular drivers instead of their location in the body," said Sandra Horning, MD, Roche's Chief Medical Officer and Head of Global Product Development.