Also known as: CELMoD agents
FDA approved iberdomide (Zenbexus) with daratumumab and dexamethasone for pretreated myeloma. The EXCALIBER-RRMM trial showed a 41% MRD-negative complete response rate vs 21%.
Multiple myeloma immunotherapies like bispecific antibodies and CAR-T cells show high response rates and prolonged survival, but access is hindered by the need for initial hospital stays for bispecifics. Research indicates mezigdomide can reverse T cell exhaustion to boost these therapies, while longer-term CARVYKTI data show significant survival benefits.
The FDA accepted Bristol Myers Squibb’s NDAs for iberdomide and mezigdomide, two CELMoD agents for relapsed/refractory multiple myeloma. Iberdomide has Priority Review and a PDUFA date of Aug. 17, 2026; mezigdomide’s is May 13, 2027. The filings are backed by Phase 3 data, including a 52% PFS risk reduction for mezigdomide.
ASCO 2026 data show CBM588 boosts immunotherapy in kidney cancer and a bispecific combo improves lymphoma. Early-day ICI infusion, mezigdomide T cell reinvigoration, and dostarlimab maintenance also advance cancer immunotherapy.
BMS's mezigdomide doubled progression-free survival in relapsed/refractory multiple myeloma at ASCO, while the FDA reviews iberdomide with a decision due by August 17. C4 Therapeutics has dosed the first patient in its Phase 2 MOMENTUM trial of cemsidomide.
An interim phase 3 analysis showed mezigdomide plus carfilzomib and dexamethasone reduced the risk of progression or death in relapsed/refractory multiple myeloma. The SUCCESSOR-2 study remains ongoing and will assess overall survival and safety.
Bristol Myers Squibb started a Phase 1 trial of BMS-986506 in clear cell renal cell carcinoma, triggering a $10 million milestone payment to Evotec SE. The candidate is the first molecular glue from the companies’ protein-degradation partnership to enter human testing.
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 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.
