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%.
The FDA granted RMAT designation to Allogene’s cema-cel for first-line LBCL consolidation and Cellectis’ lasme-cel for r/r B-ALL. Both allogeneic CAR-T therapies showed promising early efficacy and safety, with cema-cel also receiving Fast Track status.
New CAR T-cell data show 100% MRD negativity in high-risk smoldering multiple myeloma, a novel CAR T approach for AML, and a new T-cell pathway, while a case report warns of a rare therapy-related complication.
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.
FDA approved subcutaneous isatuximab-irfc for multiple myeloma. Phase 3 EMN24 trial showed 77% MRD negativity with Isa-KRd quadruplet therapy. Phase 2 study showed 77% hematologic response rate in relapsed/refractory AL amyloidosis.
Clinical trial results support ctDNA-guided therapy for bladder cancer, with the phase III IMvigor011 trial showing improved survival outcomes. Standardisation efforts are underway through position papers from professional societies and consensus guidelines. Nanotechnology advances and AI integration are poised to improve ctDNA detection sensitivity for liquid biopsy applications.
The FDA's January draft guidance proposes MRD-negative complete response as an accelerated approval end point for multiple myeloma drugs. It defines MRD negativity, sets trial design requirements, and accepts comments through March 23, 2026. Expert Nicholas Richardson discusses calibration challenges and the single-trial model.
A Labcorp Drug Development medical director shared insights on MRD testing in lung cancer, breast cancer precision strategies, and cancer research for minority populations. She highlighted a Fox Chase Cancer Center collaboration for an ultra-sensitive MRD assay and discussed progress in ESR1 mutations and oral SERDs.
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.
Studies in gastroesophageal and locally advanced rectal cancers linked dynamic ctDNA monitoring to treatment response and prognosis. MRD clearance, more than 90% ctDNA declines, and early ctDNA clearance were associated with better outcomes.
