Current status: Answered by Jenni Minto on 27 May 2025
To ask the Scottish Government what efforts it can make to ensure that access to tovorafenib can be widened in Scotland.
Tovorafenib does not currently have a marketing authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA). Before a company can place a medicine on the market in the UK it has to obtain regulatory approval by submitting data demonstrating the quality, safety and efficacy of the medicine in terms of treating a specified condition. This data is derived from clinical trials. If a marketing authorisation is granted, the Scottish Medicines Consortium (SMC) would welcome a submission for tovorafenib. The Scottish Government is aware that there is an international, phase 3 clinical trial looking at tovorafenib for the first line treatment of paediatric low-grade glioma which is open to people who meet the eligibility criteria. It is the responsibility of the clinician in charge of a patient’s care to advise on what treatment options may be available.