FDA approves efficacy supplement for Blueprint Medicines' Ayvakit

The FDA's drug approval database shows that an efficacy supplement for AYVAKIT, submission number 21, was marked approved with a status date of October 16, 2026. The sponsor is listed as Blueprint Medicines, and the submission carries a standard review priority and an efficacy submission class.¹

The record covers the oral tablet formulations of avapritinib. AYVAKIT tablets are listed in strengths of 50MG, 300MG, 100MG, 25MG, and 200MG under the active ingredient avapritinib.¹

The FDA database entry does not include further detail on what specific change or indication this efficacy supplement addresses, such as a new patient population, updated dosing information, or label expansion. The source document provides only the administrative record of approval, the application number (NDA212608), the submission type (SUPPL), and the submission class (Efficacy), without elaborating on clinical trial results or the therapeutic basis for the supplement.

Readers seeking the substantive content of this approval, such as which indication or label section was updated, would need to consult the FDA's approval letter or Blueprint Medicines' own public statements, as the openFDA drug database record does not itemize those specifics.