# Multiple myeloma treatment regulatory approvals

> Live situation record from CLSTR: https://clstr.news/situations/multiple-myeloma-treatment-regulatory-approvals
> Updated: 2026-10-15T06:30:53.000Z. Sources: 16. Developments: 2.

Regulatory authorities have granted approvals for new multiple myeloma treatments in the United States and Italy.

In September 2026, the US Food and Drug Administration (FDA) issued accelerated approval for iberdomide. This oral CELMoD class agent is intended for adult patients with relapsed or refractory multiple myeloma when used in combination with daratumumab and dexamethasone. The approval followed the Phase III EXCALIBER-RRMM study, which showed a 41% complete response rate with negative minimal residual disease in the treatment group.

In October 2026, the Italian Medicines Agency (AIFA) approved belantamab mafodotin, an antibody-drug conjugate targeting anti-Bcma, for patients experiencing their first relapse. Developed by GSK, the drug is used in combinations with either bortezomib and dexamethasone or pomalidomide and dexamethasone. Clinical trials Dreamm-7 and Dreamm-8 indicated significant improvements in survival; specifically, the Dreamm-7 study showed the combination tripled median progression-free survival to 36.6 months compared to 13.4 months for standard care, while reducing the risk of death by 42%. 

Francesca Gay, an associate professor of hematology at the University of Turin, noted that the therapy shows “superior disease control compared to current standards.” The treatment is administered intravenously, often monthly or less frequently, allowing for an aggressive initial phase that can be modulated based on patient response and toxicity. While ocular toxicity is a potential side effect, the ability to adjust infusion frequency aims to balance disease control with quality of life. GSK reported that approximately 400 patients had already been receiving the drug through access programs in nearly all hematology centers prior to formal approval.

## Timeline

### 2026-10-15: AIFA approves belantamab mafodotin for multiple myeloma in Italy

AIFA has approved belantamab mafodotin in Italy for multiple myeloma at first relapse, with clinical trials showing significantly improved progression-free survival.

12 sources. https://clstr.news/cluster/sebelipase-alfa-launched-in-italy-for-lysosomal-acid-lipase-deficiency

### 2026-09-17: FDA approves iberdomide for multiple myeloma treatment

The FDA has acceleratedly approved iberdomide in combination with daratumumab and dexamethasone for relapsed or refractory multiple myeloma, following successful results from the EXCALIBER-RRMM study.

4 sources. https://clstr.news/cluster/fda-approves-iberdomide-for-multiple-myeloma-treatment

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Cite as: Multiple myeloma treatment regulatory approvals. CLSTR, https://clstr.news/situations/multiple-myeloma-treatment-regulatory-approvals