Posted by Michael Wonder on 31 May 2020
CHMP recommends EU approval of Roche’s Rozlytrek for people with NTRK fusion-positive solid tumours and for people with ROS1-positive, advanced non-small cell lung cancer
29 May 2020 - Rozlytrek has shown durable responses across multiple tumour types, including cancer that has spread to the brain, and could become Roche’s first tumour-agnostic therapy in Europe.
Roche today announced that the EMA CHMP has adopted a positive opinion under conditional marketing authorisation for Rozlytrek (entrectinib) for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have not received a prior NTRK inhibitor, who have no satisfactory treatment options.
The CHMP has also recommended Rozlytrek for the treatment of adults with ROS1-positive, advanced non-small cell lung cancer not previously treated with ROS1 inhibitors.
