Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

EMA Recommends Extension of Therapeutic Indications for Avapritinib

It adopted two new strengths and a new indication for the treatment of advanced systemic mastocytosis
17 Feb 2022
Anticancer agents & Biologic therapy;  Haematologic malignancies

On 27 January 2022, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product avapritinib (Ayvakyt).

The marketing authorisation holder for this medicinal product is Blueprint Medicines (Netherlands) B.V.

The CHMP adopted two new strengths, 25 mg and 50 mg film coated tablets, and a new indication as follows (new text in bold):

Unresectable or metastatic gastrointestinal stromal tumour (GIST)

AYVAKYT is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic GIST harbouring the platelet-derived growth factor receptor alpha D842V mutation.

Advanced systemic mastocytosis 

AYVAKYT is indicated as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis, systemic mastocytosis with an associated haematological neoplasm or mast cell leukaemia, after at least one systemic therapy.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report, and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.  

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.