Is Avapritinib approved by the US FDA?

Drugs@FDA lists 1 application product line for Avapritinib, including AYVAKIT (Prescription).

Is Avapritinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Avapritinib: Ayvakyt.

Are there safety signals or safety updates for Avapritinib?

US FDA: 1 entry (latest 2024-11-08).

Active substance

Avapritinib

US FDA 1
EMA 1
Health Canada 4
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
AYVAKIT	100MG; 200MG; 300MG; 25MG; 50MG	tablet · oral	BLUEPRINT MEDICINES	Prescription	9 Jan 2020

EMA European Union — centrally authorised medicines

Ayvakyt Blueprint Medicines (Netherlands) B.V. · Authorised · authorised 24 Sep 2020 · ATC L01EX18

Therapeutic indication (EMA)

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).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
AYVAKYT	02551764	25 MG	TABLET · ORAL	BLUEPRINT MEDICINES CORPORATION
AYVAKYT	02551772	50 MG	TABLET · ORAL	BLUEPRINT MEDICINES CORPORATION
AYVAKYT	02551780	100 MG	TABLET · ORAL	BLUEPRINT MEDICINES CORPORATION
AYVAKYT	02551799	200 MG	TABLET · ORAL	BLUEPRINT MEDICINES CORPORATION

Safety signals and safety-related labeling changes

US FDA 8 Nov 2024 AYVAKIT — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for avapritinib →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.