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 brain
- This 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
- Rozlytrek 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).1
- In 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%.1
- Objective 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.1
- In 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).1
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