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RITUXIMAB + DHAP
RITUXIMAB + DHAP is a Monoclonal antibody, chemotherapy Small molecule drug developed by GlaxoSmithKline. It is currently in Phase 3 development for Relapsed or refractory non-Hodgkin lymphoma, Multiple myeloma.
Rituximab is a monoclonal antibody that targets and depletes CD20-positive B cells, while DHAP is a chemotherapy regimen that includes the drugs dexamethasone, high-dose cytarabine, and cisplatin.
Rituximab is an antibody that binds to the B-lymphocyte antigen CD20, classified as a binding agent. It has been studied in combination with DHAP (a chemotherapy regimen) for the treatment of Diffuse Large B-Cell Lymphoma, Lymphoma, Large-Cell, Diffuse, and Lymphoma, Mantle-Cell.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway. -
Big-pharma sponsor
+3.0pp
GlaxoSmithKline is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 + DHAP |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | Monoclonal antibody, chemotherapy |
| Target | CD20 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Rituximab works by binding to the CD20 antigen on the surface of B cells, leading to their destruction through mechanisms such as complement-dependent cytotoxicity and antibody-dependent cellular cytotoxicity. DHAP, on the other hand, is a combination chemotherapy regimen that targets rapidly dividing cancer cells. The combination of rituximab and DHAP is used to treat certain types of non-Hodgkin lymphoma.
Approved indications
- Relapsed or refractory non-Hodgkin lymphoma
- Multiple myeloma
Common side effects
- Infusion-related reactions
- Fatigue
- Nausea
- Vomiting
- Diarrhea
- Anemia
- Thrombocytopenia
- Neutropenia
Key clinical trials
- Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma (PHASE1)
- EDOCH Alternating With DHAP for New Diagnosed Younger MCL (PHASE4)
- A Trial to Learn How Effective and Safe Odronextamab is Compared to Standard of Care for Adult Participants With Previously Treated Aggressive B-cell Non-Hodgkin Lymphoma (PHASE3)
- Study of Effectiveness of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma (PHASE3)
- Zanubrutinib Combined With Standard Chemotherapy in the Treatment for Patients With Diffuse Large B Cell Lymphoma (PHASE2)
- Linperlisib Combined With Immunochemotherapy in Relapsed/Refractory LBCL (PHASE2)
- CAR-T-cell Treatment for Untreated High Risk MANtle Cell Lymphoma (PHASE2)
- R-DHAP vs POLA-R-DHAP Followed by Autologous Transplant as First Salvage Treatment in Patient With Relapsed or Refractory Diffuse Large B Cell 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 + DHAP CI brief — competitive landscape report
- RITUXIMAB + DHAP updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about RITUXIMAB + DHAP
What is RITUXIMAB + DHAP?
How does RITUXIMAB + DHAP work?
What is RITUXIMAB + DHAP used for?
Who makes RITUXIMAB + DHAP?
What drug class is RITUXIMAB + DHAP in?
What development phase is RITUXIMAB + DHAP in?
What are the side effects of RITUXIMAB + DHAP?
What does RITUXIMAB + DHAP target?
Related
- Drug class: All Monoclonal antibody, chemotherapy drugs
- Target: All drugs targeting CD20
- Manufacturer: GlaxoSmithKline — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Relapsed or refractory non-Hodgkin lymphoma
- Indication: Drugs for Multiple myeloma
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing