High-risk smoldering myeloma therapy gains US FDA approval
The US FDA approved daratumumab as monotherapy for high-risk smoldering multiple myeloma (SMM) on November 6, 2025. The approval was based on the significantly lower risk of progression to active myeloma or death and higher overall survival with daratumumab, compared to active monitoring, in the phase 3 AQUILA trial. Daratumumab was approved by the European Commission (EC) for high-risk SMM earlier in 2025.

Cilta-cel labeling changed to include Boxed Warning on immune-effector cell-associated enterocolitis
Based on a review of data from the CARTITUDE-4 trial and postmarketing adverse event reports, the US FDA approved a labeling change to include a new Boxed Warning for immune effector cell-associated enterocolitis (IEC-EC) after treatment with cilta-cel. Recommendations for patients with IEC-EC include referral to gastroenterology and infectious disease specialists, and additional work-up in cases of treatment-refractory IEC-EC.

Combination of talquetamab with daratumumab demonstrates high response rates in heavily pretreated myeloma
Findings from the phase Ib TRIMM-2 trial, reported in Blood, showed an overall response rate of 82.4% and a median progression-free survival of 21.2 months in patients with relapsed/refractory myeloma who received talquetamab-daratumumab combination therapy. These data provide proof-of-concept support for synergistic anti-myeloma activities of daratumumab and talquetamab.

Study identifies factors that increase likelihood of meeting primary endpoints in myeloma randomized trials
In a systematic review of 143 myeloma randomized controlled clinical trials, younger patient age and primary endpoints other than overall survival predicted higher likelihood of meeting primary endpoints. The analysis, reported in the Journal of the National Cancer Institute, “aims to better inform clinicians, industry, and regulators in myeloma drug development,” the authors wrote.

Panel of European myeloma experts publishes practical guidance on melflufen use
Melflufen (melphalan flufenamide) is a peptide-drug conjugate approved in the EU and UK for treating patients with relapsed/refractory myeloma. A panel of European myeloma experts published practical recommendations for optimal melflufen use, in Annals of Oncology. Melflufen is included in the 2025 EHA-EMN clinical practice guidelines. The US FDA withdrew approval for melflufen in 2024.

Positive news for accessibility of MM therapies in Australia and Canada
In Australia, daratumumab, in combination with lenalidomide and dexamethasone, is now available as frontline treatment for transplant-ineligible newly diagnosed myeloma. The Canadian Drug Agency issued positive recommendations for the reimbursement of belantamab mafodotin, with conditions, based on findings from the DREAMM-7 and -8 trials in patients with relapsed/refractory myeloma.

A new myeloma diagnostic aid gains FDA clearance
FDA Authorizes EXENT System to Aid Myeloma Diagnosis
(Targeted Oncology) “The FDA has granted 501(k) clearance to the EXENT® System, a fully automated device for assessing monoclonal gammopathies, to aid in the diagnosis of multiple myeloma. The system offers easy implementation and operation and enhances workflow efficiency, providing valuable utility for clinical laboratories.”