NDAORALCAPSULEPriority Review
Approved
Feb 2013
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
POMALYST (pomalidomide) by Bristol Myers Squibb is immunomodulatory, antiangiogenic, and antineoplastic properties. First approved in 2013.
Drug data last refreshed 18h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
POMALYST (pomalidomide) is an oral thalidomide analog that works as an immunomodulator with antiangiogenic and antineoplastic properties by targeting cereblon and degrading Aiolos and Ikaros proteins. It is primarily used to treat multiple myeloma, including lenalidomide-resistant cases, through direct cytotoxic effects and enhanced T-cell and NK-cell immunity. The drug synergizes with dexamethasone to induce tumor cell apoptosis and inhibit pro-inflammatory cytokine production.
$1.7BPart D
Peak5.5 years to LOEPOMALYST is at peak lifecycle with $1.7B in Part D spending (2023), indicating a stable, mature franchise with significant resource allocation and established commercial infrastructure.
Mechanism of Action
immunomodulatory, antiangiogenic, and antineoplastic properties. Cellular activities of pomalidomide are mediated through its target cereblon, a component of a cullin ring E3 ubiquitin ligase enzyme complex. In vitro, in the presence of drug, substrate proteins (including Aiolos and Ikaros) are…
Pharmacologic Class:
Thalidomide Analog
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Cevostamab in Combination With Pomalidomide and Dexamethasone Versus Standard of Care in Participants With Previously Treated Multiple Myeloma
Started Jun 2026
380 enrolled
Multiple Myeloma
A Study Comparing QLS32015 Monotherapy Versus Pomalidomide, Dexamethasone (Pd) or Selinexor, Dexamethasone (Sd) in Participants With Relapsed or Refractory Multiple Myeloma
Started Nov 2025
228 enrolled
Relapsed or Refractory Multiple Myeloma
A Study of JNJ-79635322 in Combination With Daratumumab With or Without Lenalidomide or in Combination With Pomalidomide for Multiple Myeloma
Started Dec 2024
140 enrolled
Multiple Myeloma
Pomalidomide for the Treatment of Bleeding in Hereditary Hemorrhagic Telangiectasia Longitudinal Assessment Study
Started May 2024
62 enrolled
Hereditary Hemorrhagic Telangiectasia (HHT)
A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortezomib, and Dexamethasone in Participants With Relapsed or Refractory Myeloma Who Have Received an Anti-CD38 Antibody and Lenalidomide
Started Jan 2024
795 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.