NDAINTRAVENOUS, SUBCUTANEOUSINJECTABLEPriority Review
Approved
May 2003
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
23
Data completeness
5/8 — Partial
Priority Review
VELCADE (bortezomib) by Takeda is proteasome inhibitors [moa]. Approved for proteasome inhibitor [epc]. First approved in 2003.
Drug data last refreshed 43m ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VELCADE (bortezomib) is a proteasome inhibitor small-molecule therapeutic approved in 2003 for multiple myeloma and mantle cell lymphoma. It works by blocking proteasome-mediated degradation of proteins, triggering apoptosis in cancer cells. The drug is administered intravenously or subcutaneously and remains a foundational agent in hematologic malignancy treatment.
$0.002BPart D
LOE ApproachingProduct is in late-stage lifecycle with modest Part D utilization; commercial teams are likely focused on retention and lifecycle management rather than expansion.
Mechanism of Action
Proteasome Inhibitors
Pharmacologic Class:
Proteasome Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (23)
A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of NXC-201 Compared With Daratumumab With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) in Newly Diagnosed Systemic AL Amyloidosis
Started Jan 2027
260 enrolled
Light Chain (AL) Amyloidosis
Linvoseltamab Versus Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone (Dara-Vcd) in Adult Participants With Newly Diagnosed Systemic Light Chain Amyloidosis
Started Dec 2026
382 enrolled
Newly Diagnosed AmyloidosisAmyloidosis Stage I-IIIA
A Trial Comparing Ramantamig and Daratumumab (Ramantamig-D) Versus Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible
Started Dec 2026
1,000 enrolled
Multiple Myeloma
Study to Evaluate Change in Disease Activity and Adverse Events of Subcutaneous Etentamig Compared With Daratumumab Plus Cyclophosphamide Plus Bortezomib Plus Dexamethasone (Dara-CyBorD) in Adults With Amyloid Light Chain (AL) Amyloidosis
Started Nov 2026
370 enrolled
Amyloid Light Chain (AL) Amyloidosis
A Study of the Combination of Belantamab Mafodotin, Bortezomib, and Dexamethasone (BVd) in Participants With Multiple Myeloma and Moderate Hepatic Impairment
Started Oct 2026
20 enrolled
Multiple Myeloma
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.