Roche gets approval in Japan for 'Rozlytrek' treatment

Roche announced on Tuesday 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.

The Swiss pharmaceuticals firm said Rozlytrek was the first tumour-agnostic medicine to be approved in Japan that targeted NTRK gene fusions, which had been identified in a range of hard-to-treat solid tumour types, including pancreatic, thyroid, salivary gland, breast, colorectal, and lung.

It had been granted ‘Sakigake’ designation and orphan drug designation by the MHLW.

Roche said Rozlytrek was 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 the first approval of Rozlytrek included the pivotal phase 2 ‘STARTRK-2’, phase 1 ‘STARTRK-1’, and phase 1 ‘ALKA-372-001’ trials, as well as data from the phase 1 and 2 ‘STARTRK-NG’ study in paediatric patients.

Roche said the results showed that in the pivotal phase 2 STARTRK-2 study, Rozlytrek shrank tumours in more than half of people with NTRK fusion-positive solid tumours.

Objective responses to Rozlytrek were seen across 10 different solid tumour types, including in people with and without CNS metastases at baseline.

It added that Rozlytrek also shrank tumours that had spread to the brain in more than half of people.

In the STARTRK-NG study, Rozlytrek shrank tumours in children and adolescents who had NTRK fusion-positive solid tumours, including the patients with primary CNS tumours.

The most commonly reported adverse reactions included constipation, altered sense of taste, diarrhoea, dizziness, fatigue, swelling, weight increase, anaemia, blood creatinine increase, shortness of breath, and nausea.

Biomarker testing for NTRK gene fusions was “the only way” to identify people who may be eligible for treatment with Rozlytrek, the company said.

Roche added that it was leveraging its expertise in developing personalised medicines and advanced diagnostics, in conjunction with Foundation Medicine, to help identify people with NTRK gene fusions using a companion diagnostic that was undergoing review.

“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 Roche’s chief medical officer and head of global product development Sandra Horning.

“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.”