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.
Phase 3 PROTEUS: perioperative apalutamide plus ADT met both dual primary endpoints in high-risk localized prostate cancer, raising pCR/MRD rates to 8.9% vs 1.0% and cutting metastasis or death risk by 20%.
A large clinical trial found that adding apalutamide to hormone therapy before and after prostate cancer surgery improves outcomes for high-risk patients. NHS England will roll out SABR radiotherapy requiring only five sessions, and new ctDNA and robotic biopsy technologies are advancing prostate cancer care.
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.
Long-term results from the phase III TRIANGLE trial show ibrutinib-based regimens improve survival in younger mantle cell lymphoma patients, while the ECHO trial establishes a new standard for older patients. Advances in CAR T-cell and bispecific antibody therapies are reshaping treatment for this rare blood cancer. The findings were presented at the annual MCL Consortium meeting.
The FDA's January draft guidance proposes MRD-negative complete response as an accelerated approval end point for multiple myeloma drugs.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 phase 2 trial in high-risk smoldering multiple myeloma found all 20 patients treated with cilta-cel became MRD-negative within two months and remained so after 15.3 months. No disease progression, death, dose-limiting toxicities, or high-grade side effects were observed.
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.
