Chemistry:Iberdomide

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Iberdomide, sold under the brand name Zenbexus, is an anti-cancer medication used for the treatment of multiple myeloma.[1] It is a cereblon-modulating protein degrader[1] and a thalidomide analog.[2]. It is taken by mouth.[1]

Iberdomide was approved for medical use in the United States in August 2026.[3]

Medical uses

Iberdomide is indicated in combination with daratumumab, hyaluronidase, and dexamethasone for the treatment of adults with multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.[3]

Adverse effects

The US prescribing information includes a boxed warning for embryo-fetal toxicity and serious venous and arterial thromboembolism, as well as warnings and precautions for neutropenia, infections, and secondary primary malignancies.[3]

History

Iberdomide was developed by Bristol Myers Squibb and has a higher binding affinity than lenalidomide or pomalidomide. It has undergone clinical trials for various cancers[4][5][6][7][8][9][10] and was also tested in people with lupus.[11]

Efficacy was evaluated in EXCALIBER-RRMM (NCT04975997), a two-stage, randomized, multi-center, open-label trial in adults with relapsed or refractory multiple myeloma who had previously received one or two prior lines of therapy.[3] People who had disease refractory to prior anti-CD38 monoclonal antibody therapy, or to prior bortezomib were excluded.[3] A total of 939 participants were randomized to one of three dose levels of iberdomide in combination with daratumumab and hyaluronidase and dexamethasone (IberDd) or to daratumumab and hyaluronidase, bortezomib and dexamethasone (DVd) in stage 1 (n=279); or to iberdomide 1 mg in combination with daratumumab and hyaluronidase and dexamethasone (Dd) or DVd in stage 2 (n=660).[3]

Society and culture

Iberdomide was approved for medical use in the United States in August 2026.[12] The U.S. Food and Drug Administration (FDA) granted the application for iberdomide priority review, breakthrough therapy, and orphan drug designations.[3]

Names

Iberdomide is the international nonproprietary name.[13]

Iberdomide is sold under the brand name Zenbexus.[14]

References

  1. ↑ 1.0 1.1 1.2 Cite error: Invalid <ref> tag; no text was provided for refs named Zenbexus FDA label
  2. ↑ Gao, Shaobing; Wang, Shichao; Song, Yongping (December 2020). "Novel immunomodulatory drugs and neo-substrates". Biomarker Research 8 (1): 2. doi:10.1186/s40364-020-0182-y. PMID 31938543. 
  3. ↑ 3.0 3.1 3.2 3.3 3.4 3.5 3.6 "FDA grants accelerated approval to iberdomide with daratumumab and hyaluronidase-fihj and dexamethasone for multiple myeloma". U.S. Food and Drug Administration (FDA). 13 August 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-iberdomide-daratumumab-and-hyaluronidase-fihj-and-dexamethasone.  Public Domain This article incorporates text from this source, which is in the public domain.
  4. ↑ Ye, Ying; Gaudy, Allison; Schafer, Peter; Thomas, Michael; Weiss, Daniel; Chen, Nianhang; Liu, Liangang; Xue, Yongjun et al. (May 2021). "First-in-Human, Single- and Multiple-Ascending-Dose Studies in Healthy Subjects to Assess Pharmacokinetics, Pharmacodynamics, and Safety/Tolerability of Iberdomide, a Novel Cereblon E3 Ligase Modulator". Clinical Pharmacology in Drug Development 10 (5): 471–485. doi:10.1002/cpdd.869. PMID 32969202. 
  5. ↑ Bjorklund, Chad C.; Kang, Jian; Amatangelo, Michael; Polonskaia, Ann; Katz, Mark; Chiu, Hsiling; Couto, Suzana; Wang, Maria et al. (April 2020). "Iberdomide (CC-220) is a potent cereblon E3 ligase modulator with antitumor and immunostimulatory activities in lenalidomide- and pomalidomide-resistant multiple myeloma cells with dysregulated CRBN" (in en). Leukemia 34 (4): 1197–1201. doi:10.1038/s41375-019-0620-8. ISSN 1476-5551. PMID 31719682. 
  6. ↑ van de Donk, Niels W.C.J.; Popat, Rakesh; Larsen, Jeremy; Minnema, Monique C.; Jagannath, Sundar; Oriol, Albert; Zonder, Jeffrey; Richardson, Paul G. et al. (5 November 2020). "First Results of Iberdomide (IBER; CC-220) in Combination with Dexamethasone (DEX) and Daratumumab (DARA) or Bortezomib (BORT) in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)". Blood 136 (Supplement 1): 16–17. doi:10.1182/blood-2020-137743. 
  7. ↑ Thieblemont, Catherine; Munoz, Javier; Tucci, Alessandra; Visco, Carlo; Cartron, Guillaume; Corradini, Paolo; Flinn, Ian W.; Gastinne, Thomas et al. (15 November 2022). "Iberdomide (CC-220) Monotherapy or in Combination with an Anti-CD20 Monoclonal Antibody As Effective Therapy in Patients with Relapsed/Refractory Lymphoma: Early Results from a Phase 1/2 Study". Blood 140 (Supplement 1): 569–572. doi:10.1182/blood-2022-162559. 
  8. ↑ Lonial, Sagar; Amatangelo, Michael; Popat, Rakesh; Minnema, Monique C.; Zonder, Jeffrey A.; Larsen, Jeremy; Oriol Rocafiguera, Albert; Campagnaro, Erica L. et al. (13 November 2019). "Translational and Clinical Evidence of a Differentiated Profile for the Novel CELMoD, Iberdomide (CC-220)". Blood 134 (Supplement_1): 3119. doi:10.1182/blood-2019-124298. 
  9. ↑ Amatangelo, Michael; Bjorklund, Chad C.; Kang, Jian; Polonskaia, Ann; Viswanatha, Sridevi; Thakurta, Anjan (29 November 2018). "Iberdomide (CC-220) Has Synergistic Anti-Tumor and Immunostimulatory Activity Against Multiple Myeloma in Combination with Both Bortezomib and Dexamethasone, or in Combination with Daratumumab in Vitro". Blood 132 (Supplement 1): 1935. doi:10.1182/blood-2018-99-113383. 
  10. ↑ Lonial, Sagar; Popat, Rakesh; Hulin, Cyrille; Jagannath, Sundar; Oriol, Albert; Richardson, Paul G; Facon, Thierry; Weisel, Katja et al. (November 2022). "Iberdomide plus dexamethasone in heavily pretreated late-line relapsed or refractory multiple myeloma (CC-220-MM-001): a multicentre, multicohort, open-label, phase 1/2 trial". The Lancet Haematology 9 (11): e822–e832. doi:10.1016/S2352-3026(22)00290-3. PMID 36209764. 
  11. ↑ Merrill, Joan T.; Werth, Victoria P.; Furie, Richard; van Vollenhoven, Ronald; Dörner, Thomas; Petronijevic, Milan; Velasco, Jorge; Majdan, Maria et al. (17 March 2022). "Phase 2 Trial of Iberdomide in Systemic Lupus Erythematosus". New England Journal of Medicine 386 (11): 1034–1045. doi:10.1056/NEJMoa2106535. PMID 35294813. 
  12. ↑ Feuerstein, Adam (2026-08-14). "FDA clears Bristol multiple myeloma therapy, marking debut of new drug class". STAT. https://www.statnews.com/2026/08/14/fda-approves-bristol-multiple-myeloma-drug-zenbexus. Retrieved 2026-08-14. 
  13. ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 79". WHO Drug Information 32 (1). 2018. 
  14. ↑ "U.S. FDA Grants Accelerated Approval to Bristol Myers Squibb's First CELMoD Therapy Zenbexus, in Combination with Daratumumab and Hyaluronidase-fihj and Dexamethasone (ZDd) for Patients with Multiple Myeloma, as Early as First Relapse". Bristol Myers Squibb (Press release). 13 August 2026. Retrieved 16 August 2026.



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