Subcutaneous isatuximab delivery via on-body injector approved in Europe and Japan
The European Commission and the Ministry of Health, Labor, and Welfare in Japan have approved subcutaneous isatuximab, delivered through an on-body injector, in combination with standard-of-care (SoC) myeloma therapies across all existing indications of isatuximab. The approval was supported by data from the phase 3 IRAKLIA study.

UK’s NICE approves daratumumab quadruplet for transplant-ineligible patients
The National Institute for Health and Care Excellence (NICE) in the UK has approved daratumumab combined with bortezomib-lenalidomide-dexamethasone (Dara-VRd) as frontline treatment for transplant-ineligible patients with newly diagnosed multiple myeloma. The approval was supported by results from the phase 3 CEPHEUS trial, which showed a 43% reduced risk of progression or death with Dara-VRd compared with VRd.

Limited-duration quadruplet therapy drives deep remission in high-risk SMM
In the phase 2 ASCENT study, fixed-duration treatment, limited to 24 cycles, with daratumumab-carfilzomib-lenalidomide-dexamethasone (Dara-KRd) yielded an overall response rate (ORR) of 97% in patients with high-risk smoldering multiple myeloma (SMM). The data, presented by IMS Vice President Shaji Kumar at the 2026 Annual Congress of the European Hematology Association (EHA 2026), also showed a 5-year progression-free survival (PFS) rate of 82%.

EMN analyses shed light on benefits of maintenance therapy approaches
According to a systematic review and network meta-analysis conducted by the European Myeloma Network, post-transplant maintenance with daratumumab-lenalidomide yielded the greatest PFS benefit, compared with observation. Per the analysis, published in the American Journal of Hematology, maintenance therapy with carfilzomib or daratumumab combined with lenalidomide, or lenalidomide alone, improved overall survival (OS) in transplant-eligible patients.

Response to bridging therapy impacts benefit from cilta-cel
According to a subgroup analysis of CARTITUDE-4 data, presented at EHA 2026, patients who achieved at least a partial response (PR) after bridging therapy had improved outcomes after infusion of ciltacabtagene autoleucel, compared to those who did not achieve ≥PR. These findings highlight the importance of optimizing bridging therapy in CAR-T candidates.

Arlo-cel yields deep and durable responses in patients with RRMM
The G protein-coupled receptor class C group 5 member D (GPRC5D)-targeted CAR-T therapy arlocabtagene autoleucel (arlo-cel) yielded an ORR of 87%, with a one-year OS rate of 90%, in patients with RRMM who had received ≥3 prior myeloma therapies, including an immunomodulatory drug, a proteasome  inhibitor, and an anti-CD38 antibody. These findings were published in Blood.