CHMP positive recommendation to change the marketing authorisation for Rozlytrek (entrectinib) - Roche

The marketing authorisation holder for this medicinal product is Roche Registration GmbH.

The CHMP adopted a new pharmaceutical form, 50 mg film-coated granules, a new gastroenteral route of administration for the 100 and 200 mg hard capsules, and an extension to an existing indication for film-coated granules and hard capsules, as follows: Neurotrophic tyrosine receptor kinase (NTRK) gene fusion; Rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients older than 1 month with solid tumours that have a NTRK gene fusion, i.who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and ii. who have not received a prior NTRK inhibitor. iii. who have no satisfactory treatment options .