Rozlytrek, Roche’s first tumour-agnostic therapy, approved in Europe for people with NTRK fusion-positive solid tumours and for people with ROS1-positive advanced non-small cell lung cancer

Rozlytrek has shown durable responses across multiple tumour types, including cancer that has spread to the brainThis approval shows the value of combining genomic profiling with precision medicine to offer patients with rare and hard-to-treat cancers a personalised treatment option             
Basel, 03 August 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has granted conditional marketing authorisation for Rozlytrek^® (entrectinib) 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, who have no satisfactory treatment options. The European Commission has also approved Rozlytrek for the treatment of adults with ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.¹Rozlytrek shrank tumours in more than half of people with NTRK fusion-positive, locally advanced or metastatic solid tumours (overall response rate [ORR]=63.5%; N=74), and objective responses were observed across 14 tumour types (median duration of response [DoR]=12.9 months [9.3 months – not reached], N=21 out of 47 patients defined by ORR).¹In ROS1-positive, advanced NSCLC, Rozlytrek shrank tumours in 73.4% of people with the disease (ORR; N=94 with a minimum of 12 months follow up), with a median DoR of 16.5 months (14.6 – 28.6 months). In a group of 161 patients with a minimum of 6 months follow up, including 29% of patients with central nervous system (CNS) metastases at baseline, ORR was observed to be 67.1%.¹Objective responses to Rozlytrek were seen in people with CNS metastases at baseline, with an intracranial ORR of 62.5% and 77.8% in both NTRK and ROS1 populations, respectively.¹In paediatric patients, Rozlytrek shrank tumours (ORR) in all children and adolescents who had NTRK gene fusions (N=5), with two achieving a complete response (CR). Two patients with primary high-grade tumours in the CNS had objective responses, including one patient with a CR.¹ Rozlytrek was well tolerated.The most common adverse reactions (≥20 percent) with Rozlytrek were fatigue, constipation, altered sense of taste (dysgeusia), swelling (oedema), dizziness, diarrhoea, nausea, nervous system disorders (dysaesthesia), shortness of breath (dyspnoea), anaemia, increased weight, increased blood creatinine, pain, cognitive disorders, vomiting, cough, and fever (pyrexia).¹Rozlytrek has been granted Priority Medicines (PRIME) designation by the EMA for the treatment of NTRK fusion-positive, locally advanced or metastatic solid tumours in adult and paediatric patients who have either progressed following prior therapies or who have no acceptable standard therapies.¹ NTRK gene fusions have been identified in a range of solid tumour types, and are present in up to 90% of some rare cancer types and less than 1% of other more common tumours, including lung and colorectal.² ROS1 gene fusions account for 1-2% of NSCLC, the most common type of lung cancer that accounts for up to 85% of all diagnoses.^3,4
Attachment03082020_MR_ Rozlytrek EC Approval_EN