Treats unresectable or metastatic GIST harboring a platelet-derived growth factor…. Sold as Ayvakit. Every FDA application for this active ingredient.
As of Nov 14, 2026, FDA lists 1 application for Avapritinib (sold as Ayvakit), first approved Jan 9, 2020, with 4 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Ayvakit | Part D | $251M | +57% | 775 |
| An Observational Study in Participants With Indolent Systemic Mastocytosis (ISM)Indolent Systemic Mastocytosis · Blueprint Medicines Corporation | — | Recruiting | Dec 4, 2025 |
| A Non-Interventional Study in Participants With Indolent Systemic Mastocytosis (ISM) in GermanyIndolent Systemic Mastocytosis · Blueprint Medicines Corporation | — | Recruiting | Dec 1, 2025 |
| MRD-positive AML Clinical StudyAML, Adult · Institute of Hematology & Blood Diseases Hospital, China | Not applicable | Recruiting | Aug 20, 2025 |
| A New Treatment of Newly Diagnosed KIT Mutation CBF-Acute Myeloid LeukemiaAcute Myeloid Leukemia With T(8;21)(Q22;Q22), Acute Myeloid Leukemia With T(16;16)(P13;Q22) · The First Affiliated Hospital of Soochow University | Phase 1 / Phase 2 | Recruiting | Jun 19, 2025 |
| Avapritinib Combined With Azacitidine and Venetoclax in the Treatment of Relapsed AML After Allo-HSCTAML (Acute Myelogenous Leukemia) · Institute of Hematology & Blood Diseases Hospital, China | Phase 2 | Recruiting | Jan 20, 2025 |
| Avapritinib Maintenance for AML With KIT MutationsAML, Adult · Ruijin Hospital | Phase 2 | Not yet recruiting | Jan 9, 2025 |
| Avapritinib Rollover StudyMastocytosis, Systemic · Blueprint Medicines Corporation | Phase 4 | Recruiting | Dec 24, 2024 |
| Avapritinib With Decitabine in Patients With SM-AHNSystemic Mastocytosis With an Associated Hematologic Neoplasm · H. Lee Moffitt Cancer Center and Research Institute | Phase 1 | Recruiting | Mar 25, 2024 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Jan 9, 2020 | AyvakitNDA 212608 · New molecular entity | Blueprint Medicines | 6 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA