Spexotras
What Spexotras is used for
Low-grade glioma 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. High-grade glioma 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.
Approved use, as published by the European Medicines Agency.
What the labels mean
- Orphan medicine: for a rare disease (affecting no more than 5 in 10,000 people in the EU).
Key facts
- Brand
- Spexotras
- Active substance
- trametinib
- Disease area
- Glioma
- Medicine group
- Antineoplastic agents
- ATC code
- L01EE01
- Marketing authorisation holder
- Novartis Europharm Limited
- Authorised in the EU since
- 2024
Official information
In the USA
Same active substance: Mekinist
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Spexotras used for?
Low-grade glioma 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. High-grade glioma 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.
What is the active substance in Spexotras?
Spexotras contains trametinib.
Who makes Spexotras?
The EU marketing authorisation holder is Novartis Europharm Limited.
Is Spexotras an orphan medicine?
Yes. Spexotras is designated an orphan medicine in the EU, for a rare disease (Glioma).
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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