CHMP recommends approval of Rozlytrek in NTRK fusion-positive solid tumours.- 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 whose solid tumours have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. 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 both in patients with locally advanced, metastatic solid tumours that display a NTRK gene fusion who have no satisfactory treatment options. 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 and paediatric patients 12 years of age and older, 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 or who have no satisfactory treatment options.