NDAORALCAPSULEPriority Review
Approved
Dec 2005
Lifecycle
LOE Approaching
Competitive Pressure
45/100
Clinical Trials
184
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
REVLIMID (lenalidomide) is an oral immunomodulatory small-molecule thalidomide analog approved in 2005 by Bristol Myers Squibb. It works through cereblon-mediated E3 ubiquitin ligase targeting, inducing degradation of key substrate proteins (Aiolos, Ikaros, CK1α) to exert direct cytotoxic and immunomodulatory effects. The drug enhances T-cell and NK-cell activation while promoting apoptosis in hematopoietic tumor cells, particularly multiple myeloma and del(5q) myelodysplastic syndromes. REVLIMID represents a foundational immunomodulatory therapy that synergizes with dexamethasone and has become a standard-of-care component in MM treatment regimens.
$3.9BPart D
1.8 years to LOEMechanism of Action
Pharmacologic Class:
Thalidomide Analog
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (184)
Belantamab Mafodotin or Daratumumab With Bortezomib, Lenalidomide and Dexamethasone for Newly Diagnosed Multiple Myeloma
Started May 2026
500 enrolled
Multiple Myeloma
A Study to Assess A Change in Disease Activity and Adverse Events of Intravenous Etentamig and Daratumumab (Etentamig+D) Compared to Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Adult Participants With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant
Started Jan 2026
660 enrolled
Multiple Myeloma
Linvoseltamab in Addition to Lenalidomide (L2) During Maintenance Therapy of NDMM to Deepen Responses or Redrive MRD Negativity After Relapse
Started Dec 2025
32 enrolled
Multiple Myeloma
Use of Isatuximab, Dexamethasone and Lenalidomide in a Go-Slow Fashion for Ultra-Frail Patients With Multiple Myeloma
Started Oct 2025
40 enrolled
Multiple MyelomaPlasma Cell Leukemia
Study of Epcoritamab in R/R Primary Diffuse Large B-cell Lymphoma of the CNS Treated With Lenalidomide and Rituximab
Started Sep 2025
60 enrolled
Primary CNS Lymphoma (PCNSL)
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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.