avapritinib
avapritinib: developed by 1 company · 6 clinical trials tracked · 1 FDA decision.
avapritinib evidence translation
What we can confirm
1 FDA record · 6 tracked trials
What it means
What to watch
Prepared research question
How could avapritinib → BPMC affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence3 indications · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Development Pipeline (2)
| Company | Phase |
|---|---|
| Blueprint Medicines Corp (BPMC) Solid Tumor, Unspecified, Child; Indolent Systemic Mastocyto… | Phase 4 |
| Blueprint Medicines Corp (BPMC) Systemic mastocytosis (SM) including advanced SM (ASM, SM-AH… | Approved |
Clinical Trials (6)
A Prospective Non-Interventional Study to Describe the Effectiveness of Avapritinib (BLU-285), a Selective KIT Mutation-Targeted Tyrosine Kinase Inhibitor, in Patients With Indolent Systemic Mastocytosis and Symptoms That Are Not Adequately Controlled With Symptomatic Treatments in Real-World Settings
Primary endpoint: Change From Baseline in Mastocytosis Control-quality of Life (MC-QoL) Questionnaire Score at Month 6
An Open-label, Multicenter, Rollover Study in Patients Who Participated in an Avapritinib Clinical Study
Primary endpoint: Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs leading to Discontinuation
A Phase 1 Study of Avapritinib in Combination With Decitabine in Patients With Systemic Mastocytosis With an Associated Hematologic Neoplasm (SM-AHN)
Primary endpoint: Recommended phase 2 dose (RP2D)
A Phase 1/2, Single-arm Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of Avapritinib in Pediatric Patients With Solid Tumors Dependent on KIT or PDGFRA Signaling
Primary endpoint: Determination of recommended Part 2 dose (Part 1)
A 3-Part, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate Safety and Efficacy of Avapritinib (BLU-285), a Selective KIT Mutation-Targeted Tyrosine Kinase Inhibitor, in Indolent and Smoldering Systemic Mastocytosis With Symptoms Inadequately Controlled With Standard Therapy
Primary endpoint: Part 1: Recommended Phase 2 dose (RP2D) in patients with ISM
An Open-label, Single Arm, Phase 2 Study to Evaluate Efficacy and Safety of Avapritinib (BLU-285), A Selective KIT Mutation-targeted Tyrosine Kinase Inhibitor, in Patients With Advanced Systemic Mastocytosis
Primary endpoint: Overall Response Rate (ORR) Based on Modified International Working Group-Myeloproliferative Neoplasms Research and Treatment and European Competence Network on Mastocytosis (mIWG-MRT-ECNM) Response Criteria
FDA Decisions1 records
Frequently asked questions
Who is developing avapritinib?
avapritinib is being developed by Blueprint Medicines Corp.
How many clinical trials involve avapritinib?
BioSniper tracks 6 clinical trials involving avapritinib.
What is avapritinib's latest FDA decision?
The most recent tracked FDA decision for avapritinib is Approval for 1 INDICATIONS AND USAGE AYVAKIT is a kinase inhibitor indicated for: Gastrointestinal Stromal Tumor (GIST) 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. ( 1.1 , 2.2 ) Advanced Systemic Mastocytosis (AdvSM) the treatment of adult patients with AdvSM. AdvSM includes patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hemato, dated January 9, 2020.