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Velcade-Dexamethasone
Velcade-Dexamethasone is a Proteasome inhibitor and corticosteroid combination Small molecule drug developed by Intergroupe Francophone du Myelome. It is currently in Phase 3 development for Multiple myeloma.
Velcade-Dexamethasone is a combination of a proteasome inhibitor and a corticosteroid used to treat multiple myeloma.
Velcade-Dexamethasone is a combination treatment that includes the small molecule Velcade (Bortezomib) and the corticosteroid Dexamethasone. It is being studied in clinical trials for various types of lymphoblastic leukemia and lymphoma, including Recurrent Acute Lymphoblastic Leukemia, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Burkitt Leukemia, Recurrent Burkitt Lymphoma, and Recurrent Childhood Lymphoblastic 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 | Velcade-Dexamethasone |
|---|---|
| Sponsor | Intergroupe Francophone du Myelome |
| Drug class | Proteasome inhibitor and corticosteroid combination |
| Target | Proteasome |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Velcade works by inhibiting the proteasome, a complex within cells that breaks down proteins. Dexamethasone is a corticosteroid that has anti-inflammatory and immunosuppressive properties. Together, they help to reduce the growth and spread of cancer cells in multiple myeloma.
Approved indications
- Multiple myeloma
Common side effects
- Neutropenia
- Thrombocytopenia
- Anemia
- Fatigue
- Diarrhea
Key clinical trials
- A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma (PHASE3)
- 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)
- A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) (PHASE3)
- 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 to Determine Dose, Safety, Tolerability and Efficacy of CC-220 Monotherapy, and in Combination With Other Treatments in Subjects With Multiple Myeloma (PHASE1, PHASE2)
- A Study to Compare Linvoseltamab Monotherapy and Linvoseltamab + Carfilzomib Combination Therapy With Standard-of-Care Combination Regimens in Adult Participants With Relapsed/Refractory Multiple Myeloma (RRMM) (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 |
|---|---|
| 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:
- Velcade-Dexamethasone CI brief — competitive landscape report
- Velcade-Dexamethasone updates RSS · CI watch RSS
- Intergroupe Francophone du Myelome portfolio CI
Frequently asked questions about Velcade-Dexamethasone
What is Velcade-Dexamethasone?
How does Velcade-Dexamethasone work?
What is Velcade-Dexamethasone used for?
Who makes Velcade-Dexamethasone?
What drug class is Velcade-Dexamethasone in?
What development phase is Velcade-Dexamethasone in?
What are the side effects of Velcade-Dexamethasone?
What does Velcade-Dexamethasone target?
Related
- Drug class: All Proteasome inhibitor and corticosteroid combination drugs
- Target: All drugs targeting Proteasome
- Manufacturer: Intergroupe Francophone du Myelome — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Multiple myeloma
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing