Japan First to Approve Roche’s Rozlytrek

Roche announced that Japan’s Ministry of Health, Labor 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).

"Today’s approval of Rozlytrek represents a new chapter in personalized 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. "We are proud to be at the forefront of personalized medicine with this novel treatment approach, and we look forward to working with regulatory agencies around the world to bring Rozlytrek to more patients with NTRK fusion-positive cancer, as well as to those with ROS1 fusion-positive NSCLC, as soon as possible."

Biomarker testing for NTRK gene fusions is the only way to identify people who may be eligible for treatment with Rozlytrek. Roche is leveraging its expertise in developing personalized medicines and advanced diagnostics, in conjunction with Foundation Medicine, to help identify people with NTRK gene fusions using a companion diagnostic that is undergoing review.

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