New methods for administering anti-CD38 monoclonal antibodies gain EMA nods
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued an approval/positive opinion on new, patient-friendlier/more convenient methods for administering anti-CD38 monoclonal antibody therapies. EMA approved subcutaneous daratumumab for administration by a patient  or caregiver, from the fifth dose onward, after appropriate training and clinician approval. Subcutaneous isatuximab via an on-body injector was also recommended for approval by EMA, supported by data from the phase 3 IRAKLIA study.

Open-access predictive tool developed for SMM risk stratification
Researchers developed a predictive model for risk-stratification in smoldering multiple myeloma (SMM) that incorporates the trajectories of four dynamic biomarkers— M-protein increase ≥0.2 g/dL, involved/uninvolved serum free light chain ratio increase ≥20, creatinine increase >25%, and hemoglobin decrease ≥1.5 g/dL. The model, named PANEGA-SMM, was reported in Nature Medicine. PANGEA-SMM is available as a free online tool for immediate use to monitor patients with SMM.

Study reports epidemiologic data on MM in the Middle East and North Africa
A targeted literature review published in Oncology and Therapy reports, for the first time, an analysis of the factors associated with myeloma incidence in the Middle East and North Africa region. Per the analysis — which included primarily retrospective observational studies, over half of which were conducted in Turkey —the median age at diagnosis of MM ranged from 43 to 70 years. Notably, use of quadruplet regimens was rare (in <1%).

Preliminary data show potential for in vivo-generated BCMA CAR
In a phase 1 trial, an immune-shielded lentiviral vector designed to transduce T cells and generate anti-BCMA CAR-T cells in vivo yielded objective responses in four of the five enrolled patients with heavily pretreated myeloma. No dose-limiting toxicities were reported; one patient died due to spinal compression from an extramedullary lesion, according to the report in Nature Medicine.

Linvoseltamab compares favorably with standard-of-care in RRMM
Linvoseltamab, a BCMA×CD3 bispecific antibody (bsAb), was approved in 2025 for treating patients with relapsed/refractory multiple myeloma (RRMM) who had received ≥3 prior lines of therapy, based on data from the phase 2 LINKER-MM1 study. In a retrospective study comparing the LINKER-MM1 cohort with an international external control arm comprised of patients who received standard-of-care, linvoseltamab yielded longer median progression-free and overall survival in patients with triple-class exposed/refractory myeloma. These results were reported in Blood Cancer Journal.

Administration of bispecific antibody therapy in community practice is feasible
While bsAb therapies are typically initiated in the inpatient setting, safe and effective outpatient administration of therapies is an area of growing interest. Indeed, a 2025 consensus report focused on this topic. A recent article in the Journal of Hematology Oncology Pharmacy showed that, “with appropriate training and protocols,” bsAbs could be administered in community practice. These data were reported previously at the 2024 IMS Annual Meeting.