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.
Zocilurtatug pelitecan showed an overall response rate of 38.2% and a disease control rate of 55.9% in 34 patients with pretreated extrapulmonary neuroendocrine carcinomas. Grade 3 or higher treatment-emergent adverse effects occurred in 30.4% of patients.
Phase 3 PSMAddition showed that adding 177Lu-PSMA-617 to ADT plus an ARPI improved radiographic progression-free survival in PSMA-positive mHSPC. Health-related quality of life and pain were largely maintained.
New antibody-based approaches demonstrate clinical benefits across multiple cancer types, including improved survival in triple-negative breast cancer, enhanced tumor detection via PET imaging, and activity in relapsed mantle cell lymphoma.
The CheckMate 743 trial reports five-year outcomes for nivolumab plus ipilimumab versus chemotherapy as first-line treatment for unresectable pleural mesothelioma, demonstrating sustained overall survival benefit.
The FDA has accepted a new drug application for tirabrutinib, a BTK inhibitor, for relapsed/refractory primary central nervous system lymphoma under the accelerated approval pathway. The regulatory agency set a PDUFA target action date of December 18, 2026.
Phase 3 LIBRETTO-432 trial met its primary endpoint, showing selpercatinib delivered statistically significant and clinically meaningful improvement in event-free survival versus placebo as adjuvant therapy in early-stage RET fusion-positive NSCLC.
