Repotrectinib
Repotrectinib (Augtyro, Bristol-Myers Squibb Pharma EEIG) has 2 EU-approved indications in 2 tumour types. Each needs a biomarker result: NTRK (1) and ROS1 (1).
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Non-small cell lung cancer1 | |||
ROS1 fusion | Monotherapy | Any line advanced | None |
| Solid tumours, tumour-agnostic1 | |||
NTRK fusion | Monotherapy | Any line advanced | Prior NTRK inhibitor, or no prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit or have been exhausted; Aged 12 years and older |
Full text of section 4.1 (therapeutic indications)
AUGTYRO as monotherapy is indicated for the treatment of adult patients with ROS1-positive advanced non-small cell lung cancer (NSCLC). AUGTYRO as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with advanced solid tumours expressing a NTRK gene fusion, and who have received a prior NTRK inhibitor, or have not received a prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit, or have been exhausted (see sections 4.4 and 5.1)
Label history
There is no record of changes to the Augtyro label that oncolabels can read yet. EMA publishes it some months after the first approval.