Also known as: CC-220
Iberdomide is a Cereblon E3 ligase modulator (CELMoD) being developed for multiple myeloma. Its clinical program spans Phase 1/2 and Phase 3 studies, and an NDA for relapsed/refractory multiple myeloma combination therapy was accepted by the FDA with a PDUFA date in 2026. It is not yet FDA approved.
Phase 3 trial data show daratumumab reduced relapse risk by 74% in NMOSD. Separately, the FDA accepted an NDA for iberdomide plus daratumumab/dexamethasone in relapsed/refractory multiple myeloma, with a PDUFA date of August 17, 2026.
The FDA has granted fast track designation to QRX003 for Netherton Syndrome and IBI3003 for relapsed or refractory multiple myeloma, while also accepting regulatory applications for other therapies addressing serious conditions with unmet medical needs.
The FDA approved Tecvayli plus Darzalex Faspro for relapsed or refractory multiple myeloma after at least one prior therapy, and accepted a new drug application for iberdomide plus daratumumab and dexamethasone with a PDUFA date of August 17, 2026.
Bristol Myers Squibb's growth portfolio increased 17% in 2025, partially offsetting a 15% decline in legacy products facing generic competition. The company's stock gained 11.4% in the past month on strong fourth-quarter results.
Bristol Myers Squibb and SystImmune reported that antibody-drug conjugate izalontamab brengitecan achieved statistically significant improvements in both progression-free and overall survival versus chemotherapy in a Phase III trial for triple-negative breast cancer.
Bristol Myers Squibb reported fourth quarter and full year 2025 results that beat consensus expectations, with total revenues of $48.3 billion. The company announced FDA acceptance of its new drug application for iberdomide and positive Phase 2 results for Reblozyl.
Novel CELMoD agents are being evaluated to address T-cell exhaustion in multiple myeloma patients, while CAR T-cell therapy CARVYKTI shows longer-term survival benefits. Nearly 200,000 people in the U.S. live with this blood cancer.
The FDA has accepted for Priority Review Bristol Myers Squibb's New Drug Application for iberdomide in combination with daratumumab and dexamethasone for relapsed or refractory multiple myeloma, with a target decision date of August 17, 2026.
The FDA has accepted Bristol Myers Squibb's new drug application for iberdomide combined with daratumumab and dexamethasone for relapsed or refractory multiple myeloma, with a target action date of August 17, 2026.
The U.S. FDA has accepted Bristol Myers Squibb's New Drug Application for iberdomide combined with daratumumab and dexamethasone in patients with relapsed or refractory multiple myeloma, with a PDUFA date of August 17, 2026.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07437963 |
Testing the Addition of Iberdomide to Therapy in People With Neuroblastoma That Has Come Back, Not Responded to Treatment, or Gotten Worse |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07434960 |
Expanded Access for Iberdomide |
AVAILABLE | |
| NCT06896916 |
Study of Intravenously (IV) Infused Etentamig in Combination With an Oral Cereblon E3 Ligase Modulatory Drug (CELMoD) Agent Assessing Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma |
RECRUITING | PHASE1 |
| NCT06785415 |
Elotuzumab, Daratumumab, Iberdomide, and Dexamethasone for the Treatment of Relapsed Multiple Myeloma |
RECRUITING | PHASE1/PHASE2 |
| NCT06762769 |
Isatuximab and Iberdomide as Immunotherapy for High Risk in Smouldering Myeloma |
RECRUITING | PHASE2 |
| NCT06518551 |
Elotuzumab + Iberdomide + Dexamethasone Post Ide-Cel in RRMM |
RECRUITING | PHASE1/PHASE2 |
| NCT06465316 |
Testing Teclistamab (TECVAYLI) in Combination With Iberdomide for Relapsed or Refractory Multiple Myeloma |
RECRUITING | PHASE1 |
| NCT06348108 |
Talquetamab in Combination With Iberdomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma |
RECRUITING | PHASE1 |
| NCT06232044 |
Testing the Combination of Two Approved Drugs and One Experimental Drug in Patients With Relapsed or Refractory Multiple Myeloma |
RECRUITING | PHASE1/PHASE2 |
| NCT06216158 |
Iberdomide vs. Iberdomide Plus Isatuximab Maintenance Therapy Post ASCT in Newly Diagnosed Multiple Myeloma |
RECRUITING | PHASE3 |
