Roche has received conditional marketing approval from the European Commission (EC) for Rozlytrek (entrectinib) to treat solid tumours in patients aged 12 years and above.
The drug is indicated for solid tumours that express a neurotrophic tyrosine receptor kinase (NTRK) gene fusion for patients with locally advanced, metastatic disease or when surgical resection may cause severe morbidity, and for those who did not have previous NTRK inhibitor therapy, without any satisfactory treatment options.
The EC has also granted approval for the drug to treat adults with ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.
Rozlytrek is a tumour-agnostic once-daily, oral tyrosine kinase inhibitor that selectively blocks the kinase activity of the TRKA / B / C and ROS1 proteins, whose activating fusions facilitate proliferation in some cancers.
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.”
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EC approval comes after a review of data from the integrated analysis of the Phase II STARTRK-2, Phase I STARTRK-1 and Phase I ALKA-372-001 clinical trials, along with results from the Phase I / II STARTRK-NG trial.
Findings showed that the drug has durable responses across a variety of NTRK gene fusion-positive solid tumours, including sarcoma, non-small cell lung, salivary MASC, secretory and non-secretory breast and thyroid, as well as ROS1-positive NSCLC.
Rozlytrek secured its first regulatory approval in June last year from Japan’s Ministry of Health, Labour and Welfare (MHLW) to treat NTRK fusion-positive, advanced recurrent solid tumours.