Roche’s first tumor agnostic therapy OK’d in Europe

As expected, the European Commission (EC) has approved Roche’s (OTCQX:RHHBY) Rozlytrek (entrectinib) for the treatment of patients at least 12 years old with solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have not received a prior NTRK inhibitor, who have no satisfactory treatment options. The EC also approved the kinase inhibitor for the treatment of adults with ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.

Entrectinib is designed to inhibit the kinase activity of the TRKA/B/C and ROS1 proteins regardless of the type of tumor expressing the gene fusions or the ROS1 enzyme.

In late May, the advisory group CHMP adopted a positive opinion backing approval.

https://seekingalpha.com/news/3598798-roches-first-tumor-agnostic-therapy-okd-in-europe