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Roche's Rozlytrek Gets Approval In Europe For Two Indications

Swiss drug maker Roche (RHHBY) announced Monday that its first tumour-agnostic therapy, Rozlytrek (entrectinib), has received conditional marketing authorisation from the European Commission.

The approval is for the treatment of people with NTRK fusion-positive solid tumours, as well as for people with ROS1-positive advanced non-small cell lung cancer.

The approval is based on results from the integrated analysis of the pivotal phase II STARTRK-2, phase I STARTRK-1 and phase I ALKA-372-001 trials, and data from the phase I/II STARTRK-NG study.

As per the studies, Rozlytrek has durable responses across several NTRK gene fusion-positive solid tumours, including sarcoma, non-small cell lung, thyroid, colorectal, neuroendocrine, and pancreatic, among others.

Rozlytrek shrank tumours in more than half of people with NTRK fusion-positive, locally advanced or metastatic solid tumours, and objective responses were observed across 14 tumour types.

Rozlytrek has been granted Priority Medicines 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.

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