POMALIDOMIDE
Pomalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients: in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy .
Details
- Status
- Prescription
- First Approved
- 2020-10-30
- Routes
- ORAL
- Dosage Forms
- CAPSULE
POMALIDOMIDE Approval History
What POMALIDOMIDE Treats
5 FDA approvalsOriginally approved for its first indication in 2020 . Covers 5 distinct patient populations.
- Other (5)
Other
(5 approvals)- • Approved indication (Oct 2020)Letter
- • Approved indication (Jan 2022)
- • Approved indication (May 2022)
- • Approved indication (Jun 2024)
- • Approved indication (Sep 2024)
POMALIDOMIDE Boxed Warning
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 ...
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 ). Poma
POMALIDOMIDE Target & Pathway
ProTarget
A pro-inflammatory cytokine that plays a central role in immune responses and inflammation. Excess TNF contributes to autoimmune diseases like rheumatoid arthritis, psoriasis, and inflammatory bowel disease. Blocking TNF reduces inflammation and prevents tissue damage.
Clinical Trial Registry
196 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06615479 | CA088-1007 | Ph 3 | recruiting | A Study to Compare the Efficacy and Safety of BMS-986393 Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma (QUINTESSENTIAL-2) |
| NCT06948084 | NCI-2025-02986 NCI-2025-02986, EAA232 | Ph 2 | not yet recruiting | 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 |
| NCT07463807 | NCI-2026-01300 NCI-2026-01300, EAA242 | Ph 1, Ph 2 | not yet recruiting | 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 |
| NCT04577755 | NCI-2020-07565 NCI-2020-07565, AMC-108 | Ph 2 | active not recruiting | Pomalidomide Treatment in Patients With Kaposi Sarcoma |
| NCT06152575 | C1071032 MAGNETISMM-32, 2023-507871-23-00 | Ph 3 | recruiting | MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide) |
| NCT05669989 | LTS17704 U1111-1277-6635, 2023-507180-19 | Ph 2 | active not recruiting | International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab |
| NCT04973605 | BGB-11417-105 2023-507751-30-00, 2021-003614-39 | Ph 1, Ph 2 | recruiting | A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma |
| NCT04181827 CARTITUDE-4 results posted | CR108695 68284528MMY3002, 2019-001413-16 | Ph 3 | active not recruiting | A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma |
| NCT05083169 MajesTEC-3 | CR109049 64007957MMY3001, 2020-004742-11 | Ph 3 | active not recruiting | A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma |
| NCT05050097 MonumenTAL-2 | CR108946 64407564MMY1004, 2020-004502-55 | Ph 1 | active not recruiting | A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma |
| NCT07222761 LINKER-MM5 | R5458-ONC-2246 2024-519504-27-00 | Ph 3 | recruiting | A Study to Compare Linvoseltamab Monotherapy and Linvoseltamab + Carfilzomib Combination Therapy With Standard-of-Care Combination Regimens in Adult Participants With Relapsed/Refractory Multiple Myeloma (RRMM) |
| NCT04108195 | CR108620 64407564MMY1002, 2019-000330-19 | Ph 1 | active not recruiting | A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma |
| NCT05438043 | CR109200 54767414MMY3030, 2021-006494-33 | Ph 3 | recruiting | A Study of Daratumumab |
| NCT04722146 MajesTEC-2 | CR108927 64007957MMY1004, 2020-004404-33 | Ph 1 | active not recruiting | A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma |
| NCT06768489 | 79635322MMY1002 79635322MMY1002, 2024-515316-44-00 | Ph 1 | recruiting | A Study of JNJ-79635322 in Combination With Daratumumab With or Without Lenalidomide or in Combination With Pomalidomide for Multiple Myeloma |
| NCT06413498 iMMagine-3 | KT-US-679-0788 2024-511188-26, jRCT2043240170 | Ph 3 | recruiting | A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma |
| NCT06106945 | D7230C00001 2023-508590-89-00 | Ph 1, Ph 2 | recruiting | AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Multiple Myeloma |
| NCT04126200 DREAMM 5 results posted | 208887 2023-509550-55-00 | Ph 1, Ph 2 | active not recruiting | Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) |
| NCT05020236 MAGNETISMM-5 | C1071005 MAGNETISMM-5, 2023-509208-14-00 | Ph 3 | recruiting | A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments |
| NCT04508790 | 19418 NCI-2020-01962, 19418 | Ph 2 | recruiting | Leflunomide, Pomalidomide, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma |
| NCT02343042 STOMP | KCP-330-017 | Ph 1, Ph 2 | active not recruiting | Selinexor and Backbone Treatments of Multiple Myeloma Patients |
| NCT07560449 | QLS4131-202 | Ph 2 | not yet recruiting | QLS4131 Combination Therapy in Malignant Plasma Cell Neoplasms |
| NCT05519085 SUCCESSOR-1 | CA057-001 2023-509859-13 | Ph 3 | recruiting | A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) |
| NCT02659930 | 160047 16-C-0047 | Ph 1 | active not recruiting | Pomalidomide in Combination With Liposomal Doxorubicin in People With Advanced or Refractory Kaposi Sarcoma |
| NCT07391657 DURGA-4 | D8311C00001 AZD0120 | Ph 3 | recruiting | A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regimens in Participants With Relapsed Refractory Multiple Myeloma (DURGA-4) |
| NCT07227311 | 224317 2025-523117-28-00 | Ph 2 | recruiting | A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Standard of Care in Participants With Relapsed-Refractory Multiple Myeloma (RRMM) |
| NCT07555938 CEVOLUTION | CO46096 2025-524028-23-00 | Ph 3 | not yet recruiting | Cevostamab in Combination With Pomalidomide and Dexamethasone Versus Standard of Care in Participants With Previously Treated Multiple Myeloma |
| NCT04902443 | 210023 21-C-0023 | Ph 1 | recruiting | Pomalidomide and Nivolumab in People With Virus-Associated Malignancies With or Without HIV |
| NCT05389423 | 10000274 000274-C | Ph 1 | recruiting | Pomalidomide and Dose-Adjusted EPOCH +/- Rituximab for HIV-Associated Lymphomas |
| NCT07096778 DoMMino-1 | CCS1477-04 1012518 | Ph 2 | recruiting | Inobrodib, Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma |
| NCT07532525 | UMCC 2025.011 NCI-2026-00885, HUM00273237 | Ph 1 | not yet recruiting | Pomalidomide After CAR T-cell Therapy for the Treatment of Relapsed or Refractory CD19+ B-cell Leukemia or Lymphoma |
| NCT07523737 | TRhos-PCNSL-01 | Ph 2 | recruiting | Pomalidomide, Anti-PD-1 Antibody Combined With Selinexor (PPS) in Relapsed/Refractory Primary Central Nervous System Diffuse Large B-Cell Lymphoma |
| NCT02719613 | CA204-185 2016-000037-51 | Ph 2 | completed | Continuing Treatment for Participants Who Have Participated in a Prior Protocol Investigating Elotuzumab |
| NCT04667663 CPD-DARA | CTRIAL-IE-19-17 2019-004386-40 | Ph 1 | active not recruiting | CPD-DARA in Patients With Relapsed/Refractory Multiple Myeloma. |
| NCT05455320 MonumenTAL-3 | CR109082 64407564MMY3002, 2021-000202-22 | Ph 3 | active not recruiting | A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment |
| NCT03601806 results posted | AMC-100 NCI-2017-00390, AMC-100 | Ph 2 | completed | Pomalidomide in Treating Patients With Kaposi Sarcoma and Human Immunodeficiency Virus Infection |
| NCT05572515 MajesTEC-9 | CR109244 64007957MMY3006, 2022-000928-37 | Ph 3 | active not recruiting | A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma |
| NCT03984097 | TAK-079-1002 U1111-1230-4820 | Ph 1 | completed | A Study to Evaluate Subcutaneous TAK-079 Added to Standard of Care Regimens in Participants With Newly Diagnosed Multiple Myeloma (NDMM) |
| NCT04925193 results posted | 20-2202.cc P30CA046934 | Ph 2 | active not recruiting | Personalized Selinexor-based Therapy for Relapsed/Refractory Multiple Myeloma |
| NCT04643002 | ACT16482 U1111-1244-2598, 2024-514988-25 | Ph 1, Ph 2 | recruiting | Isatuximab in Combination With Novel Agents in RRMM - Master Protocol |
| NCT04835129 IMPEDE | PRO00041365 | Ph 2 | active not recruiting | Isatuximab, Pomalidomide, Elotuzumab and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma |
| NCT07452198 | GR1803-004 | Ph 3 | recruiting | A Study of GR1803 Injection Versus Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Participants With Relapsed or Refractory Multiple Myeloma |
| NCT04910568 CAMMA 1 | GO42552 2021-000238-33 | Ph 1 | active not recruiting | A Study Evaluating the Safety, Pharmacokinetics, and Activity of Cevostamab in Participants With Relapsed or Refractory Multiple Myeloma |
| NCT04883242 | RG1121154 NCI-2021-03406, 10690 | Ph 2 | active not recruiting | Isatuximab, Carfilzomib, Pomalidomide, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma |
| NCT06158841 CERVINO | M22-574 2023-506668-15-00 | Ph 3 | recruiting | Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma |
| NCT06208150 MonumenTAL-6 | 64407564MMY3009 64407564MMY3009, 2022-502446-27-00 | Ph 3 | recruiting | 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 |
| NCT05730036 LINKER-MM3 | R5458-ONC-2245 2022-501396-62-00 | Ph 3 | recruiting | A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma |
| NCT04094961 | 19-291 | Ph 1, Ph 2 | active not recruiting | Ixazomib + Pomalidomide + Dexamethasone In MM |
| NCT07138209 | QLS32015-301 | Ph 3 | recruiting | A Study Comparing QLS32015 Monotherapy Versus Pomalidomide, Dexamethasone (Pd) or Selinexor, Dexamethasone (Sd) in Participants With Relapsed or Refractory Multiple Myeloma |
| NCT04270175 | 19-12021159 | Ph 2 | active not recruiting | Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Relapsed/Refractory Light Chain Amyloidosis Patients Previously Exposed to Daratumumab |
Showing 50 of 196 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
POMALIDOMIDE FDA Label Details
Indications & Usage
Pomalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients: in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy . with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART) or in patients with KS who are HIV-negative. This indication is approved under accelerated approval based on overall response rate. C...
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...
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Full clinical data, patents, trials, and competitive landscape for pomalidomide.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.