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Lenalidomide, Bortezomib
Lenalidomide, Bortezomib is a Proteasome inhibitor + Immunomodulatory agent (combination) Small molecule drug developed by University Hospital, Toulouse. It is currently in Phase 3 development for Multiple myeloma (newly diagnosed and relapsed/refractory), Mantle cell lymphoma. Also known as: Lenalidomide (REVLIMID®), Bortezomib (VELCADE®), Bortézomib (VELCADE®).
Lenalidomide and bortezomib work together to inhibit proteasome function and enhance immune-mediated tumor cell death, commonly used in multiple myeloma treatment.
Lenalidomide and bortezomib work together to inhibit proteasome function and enhance immune-mediated tumor cell death, commonly used in multiple myeloma treatment. Used for Multiple myeloma (newly diagnosed and relapsed/refractory), Mantle cell lymphoma.
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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.
| 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 | Lenalidomide, Bortezomib |
|---|---|
| Also known as | Lenalidomide (REVLIMID®), Bortezomib (VELCADE®), Bortézomib (VELCADE®) |
| Sponsor | University Hospital, Toulouse |
| Drug class | Proteasome inhibitor + Immunomodulatory agent (combination) |
| Target | 26S proteasome (bortezomib); cereblon/CRBN (lenalidomide) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Bortezomib is a proteasome inhibitor that blocks protein degradation pathways, leading to accumulation of pro-apoptotic proteins and tumor cell death. Lenalidomide is an immunomodulatory agent that enhances T-cell proliferation and NK cell activity while also providing direct anti-angiogenic and anti-proliferative effects. Together, they provide synergistic anti-myeloma activity through complementary mechanisms.
Approved indications
- Multiple myeloma (newly diagnosed and relapsed/refractory)
- Mantle cell lymphoma
Common side effects
- Peripheral neuropathy
- Thrombocytopenia
- Anemia
- Neutropenia
- Nausea
- Diarrhea
- Fatigue
- Venous thromboembolism
Key clinical trials
- Comparing the Combination of Selinexor-Daratumumab-Velcade-Dexamethasone (Dara-SVD) With the Usual Treatment (Dara-RVD) for High-Risk Newly Diagnosed Multiple Myeloma (PHASE2)
- Lenalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Multiple Myeloma (PHASE3)
- A Study of Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Newly-Diagnosed Multiple Myeloma (PHASE2)
- MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide) (PHASE3)
- A Study of Ixazomib (NINLARO®) in Combination With Lenalidomide and Dexamethasone (IRD) for the Treatment of Participants With Multiple Myeloma (MM) (PHASE4)
- A Study of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma (PHASE3)
- A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Participants With Multiple Myeloma (PHASE2)
- Minimal Residual Disease-based Strategy With T-Cell Redirector After Treatment With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (D-VRd) in Newly Diagnosed Multiple Myeloma (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:
- Lenalidomide, Bortezomib CI brief — competitive landscape report
- Lenalidomide, Bortezomib updates RSS · CI watch RSS
- University Hospital, Toulouse portfolio CI
Frequently asked questions about Lenalidomide, Bortezomib
What is Lenalidomide, Bortezomib?
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Is Lenalidomide, Bortezomib also known as anything else?
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What does Lenalidomide, Bortezomib target?
Related
- Drug class: All Proteasome inhibitor + Immunomodulatory agent (combination) drugs
- Target: All drugs targeting 26S proteasome (bortezomib); cereblon/CRBN (lenalidomide)
- Manufacturer: University Hospital, Toulouse — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Multiple myeloma (newly diagnosed and relapsed/refractory)
- Indication: Drugs for Mantle cell lymphoma
- Also known as: Lenalidomide (REVLIMID®), Bortezomib (VELCADE®), Bortézomib (VELCADE®)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing