Drug intelligence / Profile preview

naxitamab + sargramostim + isotretinoin

Development stage
Unknown
Lead developer
Y-mAbs Therapeutics
Modality
Small Molecules, Monoclonal Antibodies → Antibody-Based Therapeutics, Cytokines & Interferons → Recombinant Proteins and Enzymes
Administration
Intravenous, Subcutaneous, Oral
01

Overview

This is a **combination regimen** comprising naxitamab, sargramostim, and isotretinoin, primarily investigated for **maintenance therapy and post-consolidation treatment** in patients with **high-risk neuroblastoma**, particularly in first complete response or in relapsed/refractory cases[6]. Naxitamab is a **humanized monoclonal antibody** targeting disialoganglioside **GD2**, highly expressed in neuroblastoma cells, leading to immune-mediated cytotoxicity. **Sargramostim** (GM-CSF) is a recombinant human granulocyte-macrophage colony-stimulating factor that enhances immune effector cell activation, especially granulocytes and macrophages, facilitating antibody-dependent cellular cytotoxicity[7]. **Isotretinoin** is a retinoid (vitamin A derivative) that induces differentiation and apoptosis in neuroblastoma cells, used as a maintenance agent after intensive therapy[7]. The regimen is established in clinical trials for improving event-free and overall survival in neuroblastoma patients and is administered as cyclic intravenous (naxitamab) and subcutaneous (sargramostim) infusions, combined with oral isotretinoin[6][1][3][7].

Brand names
Danyelza (naxitamab)Leukine (sargramostim)Accutane (isotretinoin)
Other names
GM-CSF (sargramostim)13-cis-retinoic acid (isotretinoin)
02

Targets

CSF2R (Granulocyte-macrophage colony-stimulating factor receptor)RARA (Retinoic acid receptor alpha)GD2

Beyond the preview

Go deeper on naxitamab + sargramostim + isotretinoin.

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 naxitamab + sargramostim + isotretinoin.

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