A further treatment option for multiple myeloma in late-line treatment: more an unmet evidence need than an unmet medical need

Linvoseltamab is used as monotherapy for the treatment of adults with relapsed or refractory multiple myeloma who have already undergone at least three lines of treatment. In April 2025, the European Commission granted a conditional marketing authorization for this bispecific antibody. This meant that the drug was available at an early stage, even though sufficient data was not yet available to support a full marketing authorization. Such conditional marketing authorizations are possible where there is an unmet medical need – for example, in the case of severe diseases for which no treatment options are available – and the risk-benefit profile already appears promising.

“We were surprised that the European Commission granted an accelerated marketing authorization for linvoseltamab on the basis of the results of a single-arm study,” says Philip Kranz, Head of the Haemato-Oncology and Infectious Diseases Division at IQWiG. “Given the numerous existing and recently introduced treatment options, no unmet medical need is immediately apparent.” This assessment is also reflected in the Federal Joint Committee’s (G-BA’s) formulation of the research questions: Depending on the number of prior treatments (three, or four or more), an individualized treatment comprising 12 or 20 combination therapies was designated as the appropriate comparator therapy in each case. Overall, IQWiG sees no proof of an added benefit from linvoseltamab, as there is a lack of suitable data for comparison with other treatment options.

“Was the accelerated marketing authorization justified?”asks Philip Kranz. “Given the wide range of treatment options available, I see this as an unmet evidence need rather than an unmet medical need.”

The good news is that a randomized controlled trial (RCT) is already underway. The trial compares linvoseltamab versus elotuzumab in combination with pomalidomide and dexamethasone in adults with relapsed or refractory multiple myeloma who have received one to four prior treatments. The results are expected in mid-2026 – until then, the importance of linvoseltamab remains unclear.

The G‑BA decides on the extent of the added benefit

The dossier assessment is part of the early benefit assessment in accordance with the Act on the Reform of the Market for Medicinal Products (AMNOG) supervised by the G‑BA. After publication of the dossier assessment, the G‑BA conducts a commenting procedure and makes a decision on the extent of the added benefit.