Roche secures world first with Japanese Rozlytrek approval in advanced recurrent solid tumours

pharmafile | June 18, 2019 | News story | Manufacturing and Production, Sales and Marketing Cancer, Japan, Roche, Rozlytrek, pharma 

Roche’s personalised cancer therapy Rozlytrek (entrectinib) has seen its first approval: the drug has been approved in Japan for the treatment of neurotrophic tyrosine receptor kinase (NTRK) fusion-positive, advanced recurrent solid tumours in both adult and paediatric patients, it has emerged.

As well as representing Rozlytrek’s first approval worldwide, the decision also marks the first authorisation of a tumour-agnostic medicine in Japan that targets NTRK gene fusions, which have implications in the treatment of a range of solid tumour types including pancreatic, breast, lung, colorectal, lung and salivary.

The nation’s Ministry of Health, Labour and Welfare (MHLW) awarded the approval based on Phase 1 and 2 data which demonstrated that Rozlytrek achieved an objective response rate of 56.9% with a median duration of response of 10.4 months across 10 different solid tumour types in participants both with and without CNS metastases at baseline.

These data include a 50% objective response rate in 50% of participants with tumours that had spread to the brain, as well as tumour shrinkage in NTRK fusion-positive solid tumours among adolescent and paediatric patients, including those with primary CNS tumours.  

“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,” explained Dr Sandra Horning, Roche’s Chief Medical Officer and Head of Global Product Development. “We are proud to be at the forefront of personalised 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.”

Matt Fellows

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