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Rituximab, Mitoxantrone, Bendamustine
Rituximab, Mitoxantrone, Bendamustine is a Small molecule drug developed by Fondazione Italiana Linfomi - ETS. It is currently in Phase 2 development.
Rituximab is a monoclonal antibody that binds to the B-lymphocyte antigen CD20, used to treat Non-Hodgkin's Lymphoma and Follicular Lymphoma. It is often combined with other treatments, such as Bendamustine and Mitoxantrone, in clinical trials for these conditions.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Rituximab, Mitoxantrone, Bendamustine |
|---|---|
| Sponsor | Fondazione Italiana Linfomi - ETS |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Bendamustine, Mitoxantrone, and Rituximab (BMR) for Patients With Untreated High Risk Follicular Lymphoma (PHASE2)
- R-BMD in Refractory or Relapsed Lymphoma, GELTAMO Clinical Trial (PHASE2)
- Brief Chemoimmunotherapy With R+B+M Followed by R in Elderly Patients Advanced Stage Untreated Follicular Lymphoma (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Rituximab, Mitoxantrone, Bendamustine CI brief — competitive landscape report
- Rituximab, Mitoxantrone, Bendamustine updates RSS · CI watch RSS
- Fondazione Italiana Linfomi - ETS portfolio CI
Frequently asked questions about Rituximab, Mitoxantrone, Bendamustine
What is Rituximab, Mitoxantrone, Bendamustine?
Who makes Rituximab, Mitoxantrone, Bendamustine?
What development phase is Rituximab, Mitoxantrone, Bendamustine in?
Related
- Manufacturer: Fondazione Italiana Linfomi - ETS — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing