Spexotras (trametinib) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

Citation

Novartis Europharm Limited. Spexotras (trametinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/spexotras-epar-product-information_en.pdf. Revised January 2024. Accessed March 28, 2024.

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Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication Statements
Spexotras in combination with dabrafenib is indicated for the treatment of paediatric patients aged 1 year and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. 1
Spexotras in combination with dabrafenib is indicated for the treatment of paediatric patients aged 1 year and older with high-grade glioma (HGG) with a BRAF V600E mutation who have received at least one prior radiation and/or chemotherapy treatment. 1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type Biomarker(s) Cancer type Therapy(ies)
Sensitivity (+) BRAF p.V600E Low-Grade Glioma, NOS Dabrafenib, Trametinib
Sensitivity (+) BRAF p.V600E High-Grade Glioma, NOS Dabrafenib, Trametinib