The EMA has granted Priority Medicines (PRIME) designation to Rozlytrek for the treatment of NTRK fusion-positive, metastatic solid tumours
Roche secures European regulatory approval for Rozlytrek. (Credit: F. Hoffmann-La Roche Ltd.)
Swiss healthcare firm Roche has received the European Commission (EC) conditional marketing authorisation for Rozlytrek (entrectinib) to treat a type of solid tumours.
The EC approved Rozlytrek to treat metastatic solid tumours with neurotrophic tyrosine receptor kinase (NTRK) gene fusion in patients aged 12 years and older, who have not received a prior NTRK inhibitor and left with no adequate treatment options.
In addition, the drug was also approved by the EC as also for the treatment ROS1-positive, advanced non-small cell lung cancer (NSCLC) in adults, who were not previously given ROS1 inhibitors.
Roche chief medical officer and global product development head Levi Garraway said: “We are excited to announce the approval of Rozlytrek in Europe for two indications, bringing patients with NTRK and ROS1 gene fusions a new effective treatment even when their cancer has spread to the brain.
“This advance represents another important step forward in cancer care by allowing us to treat certain genetic drivers of cancer irrespective of the location of the tumour within the body. Roche is deeply committed to driving personalised healthcare and addressing the high unmet need in patients around the world with rare cancers.”
EC approval for Rozlytrek is based on results from integrated analysis of three clinical trials
Roche said that the EC approval for Rozlytrek was supported by the results from an integrated analysis of Phase 2 STARTRK-2, Phase 1 STARTRK-1 and phase I ALKA-372-001 trials, along with data from the phase 1/2 STARTRK-NG study.
In the clinical studies, Rozlytrek has shown positive results across various NTRK gene fusion-positive solid tumours.
The tumour types include sarcoma, non-small cell lung, salivary MASC, secretory and non-secretory breast, thyroid, colorectal, neuroendocrine, pancreatic, ovarian, endometrial carcinoma, cholangiocarcinoma, gastrointestinal cancers and neuroblastoma, as well as ROS1-positive NSCLC.
In addition, the drug has minimised tumours in more than 50% of patients with NTRK fusion-positive metastatic solid tumours and 73.4% patients with ROS1-positive, advanced NSCLC, within 16.5 months.
The most common adverse reactions include fatigue, constipation, dysgeusia, oedema, dizziness, diarrhoea, nausea, nervous system disorders dysaesthesia, dyspnoea, anaemia, increased weight, increased blood creatinine, pain, cognitive disorders, vomiting, cough, and fever.
Furthermore, the EMA has granted Priority Medicines (PRIME) designation to Rozlytrek for the treatment of NTRK fusion-positive, locally advanced or metastatic solid tumours patients who have no adequate standard therapies.