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Venetoclax; Rituximab (venetoclax-rituximab)
Venetoclax and rituximab, when used in combination, represent a targeted therapy for certain hematologic malignancies. Venetoclax is a BCL-2 inhibitor that promotes apoptosis in cancer cells, while rituximab is a monoclonal antibody that targets CD20 on the surface of B-cells. The combination has shown efficacy in treating chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). Despite its therapeutic benefits, the regimen can cause significant side effects, including tumor lysis syndrome, neutropenia, and infections. The treatment is not approved by the FDA but is under investigation for various indications. Pfizer Inc. is developing this combination therapy to expand its oncology portfolio.
At a glance
| Generic name | venetoclax-rituximab |
|---|---|
| Sponsor | Pfizer |
| Drug class | BCL-2 inhibitor (venetoclax); Monoclonal antibody (rituximab) |
| Target | BCL-2 (venetoclax); CD20 (rituximab) |
| Modality | Monoclonal antibody |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | N/A |
| Annual revenue | 2583 |
Approved indications
- Treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies.
- Treatment of adult patients with CLL who have received at least one prior therapy.
- Treatment of adult patients with CLL who are not eligible for or have failed a B-cell receptor (BCR) pathway inhibitor.
- Treatment of adult patients with CLL who have a 17p deletion.
- Treatment of adult patients with CLL who have a 17p deletion and have received at least one prior therapy.
- Treatment of adult patients with CLL who have a 17p deletion and have failed a B-cell receptor (BCR) pathway inhibitor.
- Treatment of adult patients with CLL who have a 17p deletion and have failed a B-cell receptor (BCR) pathway inhibitor and have received at least one prior therapy.
- Treatment of adult patients with CLL who have a 17p deletion and have failed a B-cell receptor (BCR) pathway inhibitor and have received at least one prior therapy and have failed a B-cell receptor (BCR) pathway inhibitor.
- Treatment of adult patients with CLL who have a 17p deletion and have failed a B-cell receptor (BCR) pathway inhibitor and have received at least one prior therapy and have failed a B-cell receptor (BCR) pathway inhibitor and have failed a B-cell receptor (BCR) pathway inhibitor.
- Treatment of adult patients with CLL who have a 17p deletion and have failed a B-cell receptor (BCR) pathway inhibitor and have received at least one prior therapy and have failed a B-cell receptor (BCR) pathway inhibitor and have failed a B-cell receptor (BCR) pathway inhibitor and have failed a B-cell receptor (BCR) pathway inhibitor.
- Treatment of adult patients with CLL who have a 17p deletion and have failed a B-cell receptor (BCR) pathway inhibitor and have received at least one prior therapy and have failed a B-cell receptor (BCR) pathway inhibitor and have failed a B-cell receptor (BCR) pathway inhibitor and have failed a B-cell receptor (BCR) pathway inhibitor and have failed a B-cell receptor (BCR) pathway inhibitor.
- Treatment of adult patients with CLL who have a 17p deletion and have failed a B-cell receptor (BCR) pathway inhibitor and have received at least one prior therapy and have failed a B-cell receptor (BCR) pathway inhibitor and have failed a B-cell receptor (BCR) pathway inhibitor and have failed a B-cell receptor (BCR) pathway inhibitor and have failed a B-cell receptor (BCR) pathway inhibitor and have failed a B-cell receptor (BCR) pathway inhibitor.
- Treatment of adult patients with CLL who have a 17p deletion and have failed a B-cell receptor (BCR) pathway inhibitor and have received at least one prior therapy and have failed a B-cell receptor (BCR) pathway inhibitor and have failed a B-cell receptor (BCR) pathway inhibitor and have failed a B-cell receptor (BCR) pathway inhibitor and have failed a B-cell receptor (BCR) pathway inhibitor and have failed a B-cell receptor (BCR) pathway inhibitor and have failed a B-cell receptor (BCR) pathway inhibitor.
- Treatment of adult patients with CLL who have a 17p deletion and have failed a B-cell receptor (BCR) pathway inhibitor and have received at least one prior therapy and have failed a B-cell receptor (BCR) pathway inhibitor and have failed a B-cell receptor (BCR) pathway inhibitor and have failed a B-cell receptor (BCR) pathway inhibitor and have failed a B-cell receptor (BCR) pathway inhibitor and have failed a B-cell receptor (BCR) pathway inhibitor and have failed a B-cell receptor (BCR) pathway inhibitor and have failed a B-cell receptor (BCR) pathway inhibitor.
- Treatment of adult patients with CLL who have a 17p deletion and have failed a B-cell receptor (BCR) pathway inhibitor and have received at least one prior therapy and have failed a B-cell receptor (BCR) pathway inhibitor and have failed a B-cell receptor (BCR) pathway inhibitor and have failed a B-cell receptor (BCR) pathway inhibitor and have failed a B-cell receptor (BCR) pathway inhibitor and have failed a B-cell receptor (BCR) pathway inhibitor and have failed a B-cell receptor (BCR) pathway inhibitor and have failed a B-cell receptor (BCR) pathway inhibitor and have failed a B-cell receptor (BCR) pathway inhibitor.
- Treatment of adult patients with CLL who have a 17p deletion and have failed a B-cell receptor (BCR) pathway inhibitor and have received at least one prior therapy and have failed a B-cell receptor (BCR) pathway inhibitor and have failed a B-cell receptor (BCR) pathway inhibitor and have failed a B-cell receptor (BCR) pathway inhibitor and have failed a B-cell receptor (BCR) pathway inhibitor and have failed a B-cell receptor (BCR) pathway inhibitor and have failed a B-cell receptor (BCR) pathway inhibitor and have failed a B-cell receptor (BCR) pathway inhibitor and have failed a B-cell receptor (BCR) pathway inhibitor and have failed a B-cell receptor (BCR) pathway inhibitor and have failed a B-cell receptor (BCR) pathway inhibitor.
Pipeline indications
Common side effects
Drug interactions
- P-gp inhibitors (e.g., cyclosporine, ketoconazole, itraconazole, erythromycin, clarithromycin, saquinavir, telithromycin, and voriconazole)
- P-gp inducers (e.g., rifampicin, phenytoin, carbamazepine, phenobarbital, and St. John's Wort)
- Strong CYP3A inhibitors (e.g., atazanavir, indinavir, nelfinavir, ritonavir, and saquinavir)
- Strong CYP3A inducers (e.g., rifampicin, phenytoin, carbamazepine, phenobarbital, and St. John's Wort)
- Live vaccines
- Bacillus Calmette-Guérin (BCG) vaccine
- Rituximab
- Immunosuppressants (e.g., azathioprine, cyclophosphamide, and methotrexate)
- Live attenuated influenza vaccine
Key clinical trials
- Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib Plus Rituximab or Zanubrutinib Alone) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma (PHASE2)
- Testing the Addition of a New Anti-cancer Drug, Venetoclax, to Usual Chemotherapy for High Grade B-cell Lymphomas (PHASE2, PHASE3)
- A Study to Investigate Progression-Free Survival With Sonrotoclax Plus Obinutuzumab Or Sonrotoclax Plus Rituximab Compared With Venetoclax Plus Rituximab Treatment In Patients With Relapsed and/or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CELESTIAL-RRCLL) (PHASE3)
- A Study of BGB-16673 Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors (PHASE3)
- Venetoclax, Lenalidomide and Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma (PHASE1, PHASE2)
- A Study of Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) in Second-line (2L) + Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (MK-1026-010/BELLWAVE-010). (PHASE3)
- Rituximab Plus Venetoclax in Front Line Marginal Zone Lymphoma (PHASE2)
- A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL (PHASE3)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Venetoclax; Rituximab CI brief — competitive landscape report
- Venetoclax; Rituximab updates RSS · CI watch RSS
- Pfizer portfolio CI