Overview
Avapritinib, or BLU-285, is a selective tyrosine kinase inhibitor of KIT and platelet derived growth factor receptor alpha indicated for the treatment of unresectable, metastatic gastrointestinal stromal tumors and advanced systemic mastocytosis. It is one of the first medications available for the treatment of multidrug resistant cancers. Avapritinib shares a similar mechanism with ripretinib. Avapritinib was granted FDA approval on 9 January 2020 and EMA approval on 24 September 2020.
Indication
Avapritinib is indicated for the treatment of adults with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations. It is also used to treat adult patients with advanced systemic mastocytosis (AdvSM). AdvSM includes patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia. However, it is not recommended for the treatment of patients with AdvSM with platelet counts of less than 50 X 10 L.
Associated Conditions
- Advanced Systemic Mastocytosis (AdvSM)
- Aggressive Systemic Mastocytosis
- Indolent Systemic Mastocytosis
- Mast Cell Leukemia (MCL)
- Metastatic Gastrointestinal Stromal Tumor (GIST)
- Systemic Mastocytosis With an Associated Hematological Neoplasm
- Unresectable Gastrointestinal stromal tumor
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/01/09 | Phase 2 | Not yet recruiting | |||
2024/12/24 | Phase 4 | Recruiting | |||
2024/03/25 | Phase 1 | Recruiting | |||
2024/03/19 | Phase 2 | Recruiting | Children's Hospital of Soochow University | ||
2024/01/24 | Phase 2 | Recruiting | Children's Hospital of Soochow University | ||
2023/04/20 | Phase 2 | Recruiting | The First Affiliated Hospital of Soochow University | ||
2022/05/19 | N/A | Completed | |||
2021/06/01 | Phase 1 | Completed | |||
2021/04/01 | Phase 4 | Completed | |||
2021/02/26 | Phase 1 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Blueprint Medicines Corporation | 72064-130 | ORAL | 300 mg in 1 1 | 5/24/2023 | |
| Blueprint Medicines Corporation | 72064-150 | ORAL | 50 mg in 1 1 | 5/24/2023 | |
| Blueprint Medicines Corporation | 72064-110 | ORAL | 100 mg in 1 1 | 5/24/2023 | |
| Blueprint Medicines Corporation | 72064-120 | ORAL | 200 mg in 1 1 | 5/24/2023 | |
| Blueprint Medicines Corporation | 72064-125 | ORAL | 25 mg in 1 1 | 5/24/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 9/24/2020 | ||
Authorised | 9/24/2020 | ||
Authorised | 9/24/2020 | ||
Authorised | 9/24/2020 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| AYVAKYT 100 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 1201473001 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Commercialized | |
| AYVAKYT 200 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 1201473002 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Commercialized | |
| AYVAKYT 300 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 1201473003 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Commercialized | |
| AYVAKYT 25 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 1201473004 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Commercialized | |
| AYVAKYT 50 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 1201473005 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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