Drug updated on 9/4/2024
| Dosage Form | Tablets (oral; 25 mg, 50 mg, 100 mg, 200 mg and 300 mg) |
| Drug Class | Kinase inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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.
- Indicated 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).
Latest News
Summary
- Ayvakit (avapritinib) 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; the treatment of adult patients with advanced systemic mastocytosis (AdvSM), including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SMAHN), and mast cell leukemia (MCL); and the treatment of adult patients with indolent systemic mastocytosis (ISM).
- This summary is based on the review of one systematic review(s)/meta-analysis(es). [1]
- Overall Survival (OS): Avapritinib was associated with a 56% reduction in the hazard of death compared to midostaurin, as indicated by an adjusted hazard ratio of 0.44 (95% CI: 0.25-0.76) in patients with advanced systemic mastocytosis.
- Overall Response Rate (ORR): Avapritinib demonstrated significantly higher effectiveness in achieving an overall response, with an adjusted odds ratio of 4.06 (95% CI: 3.09-5.33) compared to midostaurin.
- Complete Remission (CR): Avapritinib showed a much higher likelihood of achieving complete remission, with an adjusted odds ratio of 9.56 (95% CI: 0.97-93.81) compared to midostaurin, though the wide confidence interval suggests considerable variability.
- There is no safety information available in the reviewed studies.
- There is no population types or subgroups information available in the reviewed studies.
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 |
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 |