27 November 2025 - Multiple myeloma is a rare, incurable haematologic malignancy that demands ongoing innovation in treatment approaches given frequent disease relapse and refractory treatment. 

Recent regulatory approvals for label expansions of multiple products such as idecabtagene vicleucel and ciltacabtagene autoleucel have targeted relapsed/refractory multiple myeloma, while approvals for isatuximab and daratumumab in combination with bortezomib, lenalidomide, and dexamethasone have targeted newly diagnosed patients. 

The generation and incorporation of real-world data and evidence—evidence derived from routine clinical practice rather than interventional trials (e.g., electronic health records)—has gained momentum in regulatory applications and decision-making. This trend is particularly evident in multiple myeloma, a disease characterised by frequent cycles of remission and relapse and a rapidly evolving standard care that increasingly challenges the feasibility and relevance of traditional randomised clinical trial designs.

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