Tovorafenib

Tovorafenib (Ojemda, Ipsen Pharma) has 2 EU-approved indications in 1 tumour type. Each needs a biomarker result: BRAF (2).
Approved indications of Tovorafenib
Biomarker requirementRegimenSettingConditions
Glioma2
BRAF fusion
Monotherapy
2L
Low-grade glioma only; Progressed after one or more prior systemic therapies; Aged 6 months of age and older
BRAF V600
Monotherapy
2L
Low-grade glioma only; Progressed after one or more prior systemic therapies; Aged 6 months of age and older
Full text of section 4.1 (therapeutic indications)

Ojemda is indicated as monotherapy for the treatment of patients 6 months of age and older with paediatric low-grade glioma (LGG) harbouring a BRAF fusion or rearrangement, or BRAF V600 mutation, who have progressed after one or more prior systemic therapies (for biomarkers-based patient selection, see section 4.2).

Label history

There is no record of changes to the Ojemda label that oncolabels can read yet. EMA publishes it some months after the first approval.