CHMP recommends approval of Rozlytrek for ROS1-positive advanced non-small cell lung cancer.- Roche

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Rozlytrek (entrectinib), from Roche, intended for the treatment of patients with ROS1-positive advanced non-small cell lung cancer (NSCLC). Rozlytrek will be available as hard capsules (100 and 200 mg). Rozlytrek targets cells with constitutive activation of TRK proteins resulting from gene fusions and the proto-oncogene tyrosine-protein kinase ROS (ROS1). The benefits with Rozlytrek are considered to be its objective response rate and response duration in patients with ROS1-positive advanced NSCLC. The most common side effects are fatigue, constipation, dysgeusia, oedema, dizziness, diarrhoea, nausea, dysaesthesia, dyspnoea, anaemia, increased weight, increased blood creatinine, pain, cognitive disorders, vomiting, cough, and pyrexia. Rozlytrek as monotherapy is indicated for the treatment of adult patients with ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.