Teclistamab-daratumumab combination granted a national priority voucher in RRMM
The U.S. Food and Drug Administration (FDA) proactively awarded a national priority voucher for the combination of teclistamab and daratumumab for relapsed/refractory multiple myeloma (RRMM), based on the “outstanding results” from the phase 3 MajesTEC-3 trial. The FDA Commissioner’s National Priority Voucher is a pilot program designed to facilitate accelerated review of pharmaceutical products, reducing the review process timeline from 10-12 months to 1-2 months.

The data, presented at the at the 2025 American Society of Hematology Annual Meeting (ASH 2025), were simultaneously published in the New England Journal of Medicine.

Bispecific Combo May Offer “Functional Cure” in Multiple Myeloma

(Oncology News Central) Surbhi Sidana, MD, who moderated the ASH 2025 Session, said, “As a myeloma doctor, for me, the most exciting thing… going into the field, was all the new drugs that were coming that changed survival from two years to 15 to 20 plus years.For the first time, we are seeing the potential for cure in myeloma.”

Safety and efficacy of CAR-T therapy in dialysis-dependent patients with myeloma
Limited evidence is available to inform choice of optimal therapies in myeloma patients with significant renal impairment, as they are often excluded from clinical trials. A case series of five dialysis-dependent patients with RRMM, reported in Kidney Medicine, demonstrates the potential safety and efficacy of ciltacabtagene autoleucel. The authors highlighted the importance of dose-adjusted lymphodepleting regimens and individualized dialysis strategies.

Genomic features may help refine risk status in smoldering multiple myeloma
Diagnosis of myeloma precursor conditions — smoldering multiple myeloma (SMM) and monoclonal gammopathy of undetermined significance  — relies on clinical criteria, with improved/newer SMM risk stratification models incorporating cytogenetic features. A next-generation sequencing analysis showed that genomic alterations characteristic of MM were present in plasma cells from patients with SMM who eventually developed active MM. These findings were published in the Journal of Clinical Oncology.

Subset of mutations in cereblon may help stratify response to IMiDs vs CELMoDs
Cereblon protein, encoded by the CRBNgene, is the target of immunomodulatory drugs (IMiDs) that are the mainstay of myeloma combination therapies. Acquired mutations in CRBN contribute to IMiD-refractoriness. A study reported in Blood showed that some CRBN mutations that drive IMiD-resistance do not impact susceptibility to novel cereblon E3 ligase modulating drugs, or CElMoDs. A patient’s CRBN mutation profile may potentially inform treatment choice in the future.

Exosomal non-coding RNA may underlie sex-specific differences in myelomagenesis
The incidence of MM is higher in men, about 1.4 to 1.5 times, than in women. Non-coding RNA (ncRNA) within exosomes — extracellular vesicles released by cells that function as intracellular “messengers” — are expressed differently in bone marrow aspirates from male and female patients with myeloma. These findings, reported in the Blood Cancer Journal, highlight “the importance of exosomal ncRNA profiling in designing sex-tailored therapeutic strategies”, according to the authors.

Venous thromboembolism risk remains a challenge in MM care
The Latest on Preventing VTE in Multiple Myeloma

(MedPage Today) “Patients with multiple myeloma are at significantly increased risk of venous thromboembolism (VTE), particularly in the first year after diagnosis.

Numerous disease- and patient-related factors amplify that risk, including, for example, obesity, surgery, comorbidities, and advanced age. Novel regimens that have improved outcomes also increase the risk of VTE.”