Entrectinib

Entrectinib (Rozlytrek, Roche Registration GmbH ) has 2 EU-approved indications in 2 tumour types. Each needs a biomarker result: NTRK (1) and ROS1 (1).

Approved indications of Entrectinib
Biomarker requirement	Regimen	Setting	Conditions

Non-small cell lung cancer1
ROS1 fusion	Monotherapy	Any line advanced	No prior ROS1 inhibitor

Solid tumours, tumour-agnostic1
NTRK fusion	Monotherapy	Any line	No prior NTRK inhibitor; Older than 1 month; disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options

Full text of section 4.1 (therapeutic indications)

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.

Label history

11 changes to the Rozlytrek label since 2021, 1 of them to the indications. Newest first, in the words of EMA's record of each procedure.