Avapritinib (5) – Ayvakyt®
Advanced systemic mastocytosis, following at least one prior course of treatment
Characteristics
| Start date | 01.11.2025 – Marketing authorisation: 24.03.2022 |
|---|---|
| Resolution | 16.04.2026 |
| INN | Avapritinib |
| Brand name | Ayvakyt® |
| Pharm. company | Blueprint Medicines (Germany) GmbH |
| G-BA Procedure ID | D-1262 |
| ATC code | L01EX18 Other protein kinase inhibitors (L01EX) |
| Therapeutic area | Oncological diseases Orphan (turnover limit) |
| Reason for procedure | Reassessment: Orphan turnover exceeded |
Studies and Results
- Clinical trials
- The PATHFINDER trial is an open-label, multicentre, single-arm Phase II trial of avapritinib for the treatment of adults with advanced systemic mastocytosis.
- The EXPLORER trial is an open-label, multicentre, single-arm Phase I trial of avapritinib for the treatment of adult patients with advanced systemic mastocytosis, comprising a dose-escalation phase (Part 1) and an extension phase (Part 2).
Adults with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasia (SM-AHN) or mast cell leukaemia (MCL) who have received at least one course of systemic therapy
- An additional benefit is not proven.
- The single-arm studies PATHFINDER and EXPLORER submitted by the pharmaceutical manufacturer do not allow for a comparison with the appropriate comparator therapy. Consequently, there are no data available to enable an assessment of the additional benefit.
Courtesy translation only, please refer to the German original.
Associated procedures
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