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

On Jun 19, 2019

Roche 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. 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 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. “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.”

The data package for this first approval of Rozlytrek 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. Results showed:

In the pivotal Phase II STARTRK-2 study, Rozlytrek shrank tumours in more than half (objective response rate [ORR] = 56.9 percent) of people with NTRK fusion-positive solid tumours. Objective responses to Rozlytrek were seen across 10 different solid tumour types (median duration of response [DoR] = 10.4 months), including in people with and without CNS metastases at baseline.
- Importantly, Rozlytrek also shrank tumours that had spread to the brain in more than half of people (intracranial response [IC] ORR = 50.0 percent).
In the STARTRK-NG study, Rozlytrek shrank tumours also in children and adolescents who had NTRK fusion-positive solid tumours including the patients with primary CNS tumours.
The most commonly reported adverse reactions include constipation, altered sense of taste (dysgeusia), diarrhoea, dizziness, fatigue, swelling (oedema), weight increase, anaemia, blood creatinine increase, shortness of breath (dyspnea), and nausea.

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 personalised 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.