Drug updated on 4/26/2024
| Dosage Form | Tablet (oral:25mg, 50mg, 100 mg, 200 mg, 300 mg) |
| Drug Class | Kinase inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations.
- For the treatment of adult patients with advanced systematic mastocytosis (AdvSM). AdvSM includes patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SMAHN), and mast cell leukemia (MCL).
- Indicated for the treatment of adult patients with indolent systemic mastocytosis (ISM).
Summary
- Avapritinib (Ayvakit) is indicated for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations.
- Additionally, avapritinib (Ayvakit) is used in treating adult patients with advanced systematic mastocytosis which includes aggressive systemic mastocytosis, systemic mastocytosis with an associated hematological neoplasm and mast cell leukemia.
- A systematic review was conducted to compare the efficacy of avapritinib versus midostaurin in patients suffering from advanced systemic mastocytosis.
- The clinical trials EXPLORER and PATHFINDER were identified during the literature review that investigated avapritinib's effectiveness against midostaurin using unanchored matching-adjusted indirect comparisons for overall survival rate, overall response rate and complete remission.
- According to these studies' results, when compared to midostaurin therapy for advanced systemic mastocytosis patients, avapritnib showed improved survival rates - adjusted hazard ratio being 0.44 along with better response rates - odds ratios being 4.06 for ORR and 9.56 for CR respectively.
- Available evidence suggests that Avaprtitinb (Ayvakit), when compared to Midostarin has shown significant improvement in terms of patient survival rates as well as their responses towards treatment making it a potentially more effective choice among health professionals dealing with Advanced Systemic Mastocyctois (AdvSM).
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Ayvakit (avapritinib) Prescribing Information. | 2023 | Blueprint Medicines Corporation, Cambridge, MA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Indirect treatment comparisons of avapritinib versus midostaurin for patients with advanced systemic mastocytosis. | 2022 | Future oncology |
| Avapritinib for treating unresectable or metastatic gastrointestinal stromal tumours. | 2020 | NICE |
| Assessment report: Ayvakyt. | 2020 | EMA |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| 2023 GEIS guidelines for gastrointestinal stromal tumors. | 2023 | Therapeutic Advance in Medical Oncology |
| NCCN guidelines insights: gastrointestinal stromal tumors, version 2.2022. | 2022 | Official Journal of the National Comprehensive Cancer Network |
| Gastrointestinal stromal tumours: ESMO – EURACAN - GENTURIS Clinical Practice Guidelines for diagnosis, treatment and follow-up. | 2021 | Annals of Oncology |