EMA — authorised 24 September 2020
- Marketing authorisation holder: Blueprint Medicines (Netherlands) B.V.
- Status: approved
🇪🇺 Ayvakit in European Union
EMA authorised Ayvakit on 24 September 2020
Marketing authorisations
EMA — authorised 24 September 2020
- Application: EMEA/H/C/005208
- Marketing authorisation holder: Blueprint Medicines (Netherlands) B.V.
- Local brand name: Ayvakyt
- Indication: Unresectable or metastatic gastrointestinal stromal tumour (GIST) AYVAKYT is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (GIST) harbouring the platelet-derived growth factor receptor alpha (PDGFRA) D842V mutation. Advanced systemic mastocytosis (AdvSM) AYVAKYT is indicated as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated haematological neoplasm (SM-AHN) or mast cell leukaemia (MCL), after at least one systemic therapy. Indolen
- Pathway: conditional, orphan
- Status: approved
Ayvakit in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in European Union
Frequently asked questions
Is Ayvakit approved in European Union?
Yes. EMA authorised it on 24 September 2020; EMA authorised it on 24 September 2020.
Who is the marketing authorisation holder for Ayvakit in European Union?
Blueprint Medicines (Netherlands) B.V. holds the EU marketing authorisation.