Drug intelligence / Profile preview

gilteritinib + venetoclax + azacitidine + cytarabine

Development stage
Unknown
Lead developer
Astellas Pharma Global Development, Inc.
Modality
Small Molecules
Administration
Oral, Intravenous, Subcutaneous
01

Overview

This combination regimen, evaluated in the GANCE trial by the First Affiliated Hospital of Zhejiang University, is a multi-phase treatment strategy for newly diagnosed, intermediate-risk acute myeloid leukemia (AML) patients with FLT3-ITD mutations. The regimen consists of an induction phase using 'GVA' (gilteritinib, venetoclax, and azacitidine) followed by a consolidation phase using high-dose cytarabine (HiDAC) and gilteritinib, and a final maintenance phase with gilteritinib. Gilteritinib is a potent FLT3 inhibitor, venetoclax is a BCL-2 inhibitor that promotes apoptosis, azacitidine is a hypomethylating agent, and cytarabine is a pyrimidine analog that interferes with DNA synthesis. This approach aims to achieve deep molecular remission and potentially replace the need for allogeneic hematopoietic stem cell transplantation in fit patients. Note: The term 'HDAC' in the trial context refers to High-Dose Ara-C (cytarabine), rather than a histone deacetylase inhibitor.

Brand names
VenclextaVidazaCytosar-U
Other names
GVA + HiDACGVA + HDAC ConsolidationGilteritinib + VA RegimenGVA + histone deacetylase inhibitor + gilteritinib
02

Targets

BCL-2 (BCL-2 family)AXL (AXL receptor tyrosine kinase)DNMT (DNA methyltransferase)DNAFLT3 (Fms related receptor tyrosine kinase 3)

Beyond the preview

Go deeper on gilteritinib + venetoclax + azacitidine + cytarabine.

Explore the evidence, development activity, and competitive landscape with Gosset’s full data platform.

Clinical trials

Full profile access

Follow clinical development from study design and recruitment through results.

  • Trial phase
  • Status
  • Readouts

Indications & development

Full profile access

Explore development by indication, patient population, and geography.

  • Indications
  • Development status
  • Countries

Licensing & deals

Full profile access

Trace asset ownership, licensing agreements, and commercial partnerships.

  • Partners
  • Deal terms
  • Milestones

Patents & exclusivity

Full profile access

Explore the patent landscape and regulatory exclusivity around an asset.

  • Patents
  • Expiration dates
  • Exclusivity

Competitive landscape

Full profile access

Compare development programs by target, modality, and indication.

  • Competing assets
  • Targets
  • Development stage

Research & analysis

Full profile access

Connect source evidence and development news to your research questions.

  • Publications
  • News
  • Analysis

Bring the full picture into focus.

See how Gosset can support your research on gilteritinib + venetoclax + azacitidine + cytarabine.

Explore the full profile

Gosset Free

Get started with Gosset.

Enter your work email and we’ll be in touch with next steps.

Work email preferred.

Book a call