Drug intelligence / Profile preview

fludarabine + mitoxantrone + rituximab

Development stage
Phase 3
Lead developer
Bayer
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules
Administration
Intravenous
01

Overview

The combination of fludarabine, mitoxantrone, and rituximab (often abbreviated as FMR) is a chemoimmunotherapy regimen used primarily for treating hematological malignancies, particularly chronic lymphocytic leukemia (CLL) and certain types of non-Hodgkin lymphoma. ## Description Fludarabine + mitoxantrone + rituximab (FMR) is a combination chemoimmunotherapy regimen that brings together three distinct mechanisms of action to treat hematological malignancies. This regimen combines: 1. **Fludarabine**: A purine analog antimetabolite that inhibits DNA synthesis by interfering with DNA polymerase and ribonucleotide reductase, leading to cell death in both dividing and resting lymphocytes. 2. **Mitoxantrone**: An anthracenedione antineoplastic agent that intercalates with DNA, causing cross-links and strand breaks, and inhibits topoisomerase II, disrupting DNA repair. 3. **Rituximab**: A chimeric monoclonal antibody targeting CD20 antigen on B-lymphocytes, causing cell death through complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity, and direct induction of apoptosis. Clinical trials have shown this combination to be highly effective in previously untreated chronic lymphocytic leukemia (CLL), with response rates up to 93% and complete response rates of 82%. The regimen has demonstrated effectiveness in achieving minimal residual disease (MRD)-negative complete responses in a significant proportion of patients. FMR has also shown promise in treating relapsed mantle cell lymphoma and follicular lymphoma.

Other names
Fludarabine-mitoxantrone-rituximab
02

Targets

DNACD20 (B-lymphocyte antigen CD20)RNR (Ribonucleotide reductase)DNA polymerase familyTOP2A (DNA topoisomerase II)

Beyond the preview

Go deeper on fludarabine + mitoxantrone + rituximab.

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 fludarabine + mitoxantrone + rituximab.

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