On 25 April 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Rozlytrek. 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:1
Neurotrophic tyrosine receptor kinase (NTRK) gene fusion
Rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older than 1 month with solid tumours expressingthat have 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 (see sections 4.4 and 5.1).
For information, the full indications for Rozlytrek will be 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,
- 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 (see sections 4.4 and 5.1).
ROS1 gene fusion
Rozlytrek as monotherapy is indicated for the treatment of adult patients with ROS1‑positive, advanced non‑small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.
Treatment with Rozlytrek should be prescribed by a physician experienced
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR) and made available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
1New text in bold, removed text as strikethrough.
CHMP post-authorisation summary of positive opinion for Rozlytrek (X-17-G)
English (EN) (167.72 KB - PDF)