Drug Detail

Information about AYVAKIT

Generic Name
Avapritinib
IND
BLU-285
Brand Name (US)
AYVAKIT
Manufacturer
Blueprint Medicines
Drug Type
Tyrosine Kinase Inhibitor
Delivery
Oral
Approval Status
Approved for GISTS with PDGFRA exon 18 mutations
Indications
GIST, SM
Overall Strategy
KIT Protein Based
Strategy
Block KIT/PDGFRA
Drug Category
KIT/PDGFRA inhibitor + D842V inhibitor

Avapritinib is FDA approved for treatment of adults with unresectable or metastatic GISTs that have mutations in PDGDFRA exon 18 including the D842V mutation.
It is approved for patients in any line of treatment, for example, 1st line, 2nd line, etc., but it is not approved for adjuvant treatment (preventative).


Links

 

AYVAKIT.com website, resources for patients, support program, etc.
   

 

Avapritinib prescribing information
   

 

2017 AACR BLU-285 Presentation by Blueprint
   

 

2019 ASCO - Clinical activity of avapritinib in 4L or greater GIST including PDGFRA exon 18 and D842V
   

 

2016 EEORTC-NIH-AACR Munich Heinrich presentation
   

 

Summary of Risk Management Plan for AYVAKYT (Avapritinib) - An EMA summary (PDF)
   

 

2017 AACR KU Leuven Abstract (
   

 

Blueprint programs
   

 

LRG Story: Update on Blueprint Medicines Clinical Trial for BLU-285
   

 

BLU-285 in GIST at AACR 2015
   

 

AACR 2015 Abstract #791: BLU-285, the first selective inhibitor of PDGFRα D842V and KIT Exon 17 mutants
   

Trials of this drug

  

(NAVIGATOR) Study of BLU-285 in Patients With Gastrointestinal Stromal Tumors (GIST) and Other Relapsed and Refractory Solid Tumors
   

  

Early Access Program (EAP) for Avapritinib in Patients With Locally Advanced Unresectable or Metastatic GIST
   

Trial results

  The Oncologist 1/16/2021: Avapritinib in Patients With Advanced Gastrointestinal StromalTumors Following at Least 3 Prior Lines of Therapy
   
  Heinrich webcast from EORTC-NCI-AACR Meeting 12/1/2016
   
  EORTC-NIC-AACR 2016 Munich - Heinrich Presentation
   
  Blueprint Press Release 12/1/2016
   
  Abstract: Preliminary safety and activity in a first-in-humans phase 1 study of BLU-285 ... in GIST
   

Search for this drug/combination in:

ClinicalTrials.gov

ASCO

Pubmed