NDAORALCAPSULEPriority Review
Approved
Dec 2005
Lifecycle
LOE Approaching
Competitive Pressure
45/100
Clinical Trials
181
Data completeness
5/8 — Partial
Priority Review
REVLIMID (lenalidomide) by Bristol Myers Squibb. Approved for thalidomide analog [epc]. First approved in 2005.
Drug data last refreshed 6h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
REVLIMID (lenalidomide) is an oral thalidomide analog small molecule approved in 2005 for multiple myeloma and other hematologic malignancies. It works as an immunomodulatory agent, enhancing T-cell proliferation and NK cell activity while exhibiting direct anti-tumor effects. The drug is a cornerstone therapy in oncology with broad clinical utility across multiple blood cancers.
$3.9BPart D
LOE Approaching1.7 years to LOEPeak-revenue mature asset approaching loss of exclusivity; expect defensive portfolio focus and transition planning across commercial and clinical teams.
Mechanism 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 (181)
Belantamab Mafodotin or Daratumumab With Bortezomib, Lenalidomide and Dexamethasone for Newly Diagnosed Multiple Myeloma
Started Jul 2026
500 enrolled
Multiple Myeloma
Lenalidomide Plus Targeted Therapy and Immunotherapy for Refractory HCC
Started Jun 2026
32 enrolled
Hepatocellular Carcinoma (HCC)
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
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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.