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Pomalyst (pomalidomide)

Pomalyst works by binding to the cereblon protein, which disrupts the function of certain genes involved in cancer cell growth.

Pomalyst (pomalidomide) is a thalidomide analog small molecule developed by Celgene and currently owned by Bristol. It targets the protein cereblon and is used to treat multiple myeloma. Pomalyst was FDA-approved in 2013 and has six generic manufacturers. The commercial status of Pomalyst is not off-patent, and it has a half-life of 9.5 hours. Key safety considerations include its potential for teratogenicity and neuropathy.

At a glance

Mechanism of action

Pomalidomide is an analogue of thalidomide with immunomodulatory, antiangiogenic, and antineoplastic properties. Cellular activities of pomalidomide are mediated through its target cereblon, component of cullin ring E3 ubiquitin ligase enzyme complex. In vitro, in the presence of drug, substrate proteins (including Aiolos and Ikaros) are targeted for ubiquitination and subsequent degradation leading to direct cytotoxic and immunomodulatory effects. In in vitro cellular assays, pomalidomide inhibited proliferation and induced apoptosis of hematopoietic tumor cells. Additionally, pomalidomide inhibited the proliferation of lenalidomide-resistant multiple myeloma (MM) cell lines and synergized with dexamethasone in both lenalidomide-sensitive and lenalidomide-resistant cell lines to induce tumor cell apoptosis. Pomalidomide enhanced cell- and natural killer (NK) cell-mediated immunity and inhibited production of pro-inflammatory cytokines (e.g., TNF- and IL-6) by

Approved indications

• Multiple myeloma

Boxed warnings

• BOXED WARNING WARNING: EMBRYO-FETAL TOXICITY and VENOUS AND ARTERIAL THROMBOEMBOLISM Embryo-Fetal Toxicity Pomalidomide capsules are contraindicated in pregnancy. Pomalidomide capsules are a thalidomide analogue. Thalidomide is a known human teratogen that causes severe birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting pomalidomide capsules treatment. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after stopping pomalidomide capsules treatment [see Contraindications (4), Warnings and Precautions (5.1) and Use in Specific Populations (8.1, 8.3 )]. Pomalidomide capsules are only available through a restricted distribution program called PS-Pomalidomide REMS [see Warnings and Precautions (5.2 )]. Information about PS-Pomalidomide REMS is available at www.PS-PomalidomideREMS.com or by calling the REMS Call Center at 1-888-423-5436. Venous and Arterial Thromboembolism Deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke occur in patients with multiple myeloma treated with pomalidomide capsules. Prophylactic antithrombotic measures were employed in clinical trials. Thromboprophylaxis is recommended, and the choice of regimen should be based on assessment of the patient's underlying risk factors [see Warnings and Precautions (5.3 )]. WARNING: EMBRYO-FETAL TOXICITY and VENOUS AND ARTERIAL THROMBOEMBOLISM See full prescribing information for complete boxed warning EMBRYO-FETAL TOXICITY Pomalidomide capsules are contraindicated in pregnancy. Pomalidomide capsules are a thalidomide analogue. Thalidomide is a known human teratogen that causes severe life-threatening birth defects ( 4, 5.1, 8.1 ). For females of reproductive potential: Exclude pregnancy before start of treatment. Prevent pregnancy during treatment by the use of 2 reliable methods of contraception ( 5.1, 8.3 ). Pomalidomide capsules are available only through a restricted program called PS-Pomalidomide REMS ( 5.2 ). VENOUS AND ARTERIAL THROMBOEMBOLISM Deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke occur in patients with multiple myeloma treated with pomalidomide capsules. Antithrombotic prophylaxis is recommended ( 5.3 ).

Common side effects

• Neutropenia
• Fatigue and asthenia
• Anemia
• Constipation
• Nausea
• Diarrhea
• Dyspnea
• Upper respiratory tract infection
• Back pain
• Pyrexia
• Thrombocytopenia
• Leukopenia

Key clinical trials

• Pomalidomide for Kaposi Sarcoma in People With or Without HIV (PHASE1,PHASE2)
• A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma (PHASE3)
• Testing the Investigational Medication Combination of Teclistamab and Pomalidomide Compared to the Usual Treatment (Carfilzomib, Pomalidomide, and Dexamethasone) for Patients With Multiple Myeloma Who Have Relapsed Shortly After Treatment (PHASE1,PHASE2)
• Testing the Investigational Medication Combination of Daratumumab and Teclistamab Compared to the Usual Treatment (Daratumumab, Pomalidomide, Dexamethasone or Daratumumab, Carfilzomib, Dexamethasone) for Patients With High-risk Multiple Myeloma Refractory or in First Relapse (PHASE2)
• A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments (PHASE3)
• Isatuximab, Pomalidomide, Elotuzumab and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma (PHASE2)
• A Study of GR1803 Injection Versus Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Participants With Relapsed or Refractory Multiple Myeloma (PHASE3)
• A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) (PHASE3)

Patents

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Pomalyst CI brief — competitive landscape report
• Pomalyst updates RSS · CI watch RSS
• Bristol-Myers Squibb portfolio CI