Roche: EMA greenlights Rozylytrek treatment

(CercleFinance.com) - On Friday Roche announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion under conditional marketing authorisation for Rozlytrek (entrectinib) for the treatment.


The CHMP has also recommended Rozlytrek for the treatment of adults with ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.

"Once approved, Rozlytrek could become Roche's first tumour-agnostic therapy in Europe," said Levi Garraway, Roche's Chief Medical Officer and Head of Global Product Development.

"Based on genomic testing, Rozlytrek provides an effective first-line treatment for many people whose cancers harbour NTRK or ROS1 gene fusions, including tumours that have progressed to the brain".


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