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Roche: CHMP Recommends EU Approval Of Rozlytrek To Treat NTRK Fusion-positive Tumours

Roche (RHHBY) announced the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion under conditional marketing authorisation for Rozlytrek for people with NTRK fusion-positive solid tumours and for people with ROS1-positive, advanced non-small cell lung cancer. A final decision regarding the approval is expected in the coming months.

Rozlytrek was granted accelerated approval in August 2019 by the US FDA, following receipt of Breakthrough Therapy designation, for the treatment of adult and paediatric patients 12 years of age and older with solid tumours that have a NTRK gene fusion, and was approved for the treatment of adults with ROS1-positive, metastatic NSCLC.

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