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 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
POMALYST (pomalidomide) is an oral thalidomide analog with immunomodulatory, antiangiogenic, and antineoplastic properties that works by targeting cereblon to degrade Aiolos and Ikaros proteins, triggering tumor cell apoptosis and enhancing immune response. It is indicated for multiple myeloma, including lenalidomide-resistant disease. The drug demonstrates synergy with dexamethasone and overcomes resistance mechanisms, making it a critical salvage therapy option.
$1.7BPart D
PeakStable
5.2 years to LOEPeak-stage product generating $1.7B in Part D spending with a stable 78,733 annual claims base, supporting a large and stable commercial organization at Bristol Myers Squibb.
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)
A Study to Evaluate Adverse Events and Change in Disease Activity With Injected Etentamig Plus Oral Pomalidomide Versus Standard Therapies in Adults With Relapsed or Refractory Multiple Myeloma
Started Nov 2026
520 enrolled
Relapsed or Refractory Multiple Myeloma
Comparing Lower Versus Standard Doses of Belantamab Mafodotin With Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma.
Started Oct 2026
228 enrolled
Relapsed / Refractory Multiple Myeloma
Cevostamab in Combination With Pomalidomide and Dexamethasone After BCMA- Targeting CAR T-Cell Therapy in Participants With Previously Treated Multiple Myeloma
Started Oct 2026
45 enrolled
Multiple Myeloma
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
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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.