Ayvakyt (avapritinib)
- Region
- 🇪🇺 EU
- Active substance
- avapritinib
- Company
- Blueprint Medicines (Netherlands) B.V.
- Status
- Authorised
- Therapeutic area
- Gastrointestinal Stromal Tumors
- CHMP opinion
- Thu 23 Jul 2020
- EU approval
- Thu 24 Sep 2020
- Designations
- Orphan, Conditional, Additional monitoring
- Application
- EMEA/H/C/005208
- ATC
- L01EX18
- Official record
- www.ema.europa.eu
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. Indolent systemic mastocytosis (ISM) AYVAKYT is indicated for the treatment of adult patients with indolent systemic mastocytosis (ISM) with moderate to severe symptoms inadequately controlled on symptomatic treatment (see section 5.1).
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.