The European Commission (EC) has granted conditional marketing authorisation for Rozlytrek (entrectinib) for the treatment of advanced solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.
Following the approval, adults and paediatric patients aged 12 years or over with locally advanced, metastatic NTRK-positive tumours will be able to access Rozlytrek.
Patients must also not have been previously treated with a prior NTRK inhibitor, and have no satisfactory treatment options.
Alongside this authorisation, the EC has also approved Rozlytrek for the treatment of adults with ROS-1 positive, advanced non-small cell lung cancer (NSCLC) who have not been previously treated with a ROS1 inhibitor.
The approval is based on results from the pivotal phase 2 STARTRK-2, phase 1 STARTRK-1 and phase 1 ALKA-372-001 trials, as well as data from the phase 2/3 STARTRK-NG study.
Across these studies, Rozlytrek produced durable responses across several NTRK gene fusion-positive solid tumours, including sarcoma, non-small cell lung, salivary MASC, secretory and non-secretory breast, thyroid and more.
Rozlytrek shrank tumours in over half of people with NTRK fusion-positive, locally advanced or metastatic solid tumours and an objective response rate was observed across 14 tumour types.
In ROS1-positive NSCLC, Rozlytrek also shrank tumours in 73.4% of people tested in the studies.
“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,” said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development.
“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,” he added.
Rozlytrek was granted accelerated approval by the US Food and Drug Administration (FDA) in August 2019 for the treatment of adult and paediatric patients aged 12 years or over with NTRK fusion-positive solid tumours without a known acquired resistance mutation.