New treatment option for multiple myeloma: Unclear benefit due to lack of comparative data
Linvoseltamab is approved as monotherapy for adults with relapsed and refractory multiple myeloma who have received at least three prior therapies. The EU Commission granted conditional approval to the bispecific antibody in April 2025. This enables early use, although complete data for regular approval is missing. Conditional marketing authorisations apply in the event of unmet medical need, for example in the case of serious illness without alternatives, if the benefit-risk ratio appears promising.
The active ingredient was approved on the basis of a single-arm study. IQWiG considers this to be surprising, as there are numerous treatment options and an unmet medical need is not obvious. Instead, the institute sees a lack of evidence. Depending on the number of previous therapies, the G-BA has defined individualized comparative therapies with 12 or 20 combinations. IQWiG finds no evidence of an additional benefit of linvoseltamab due to a lack of comparative data.
An ongoing randomized controlled trial compares linvoseltamab with elotuzumab plus pomalidomide and dexamethasone in patients on one to four prior therapies. Results are expected in mid-2026. Until then, the significance remains unclear.
The dossier assessment is part of the early benefit assessment according to AMNOG. The G-BA conducts a comment procedure and decides on the extent of the additional benefit.
Original Paper:
https://www.iqwig.de/projekte/a25-127.html
Editor: X-Press Journalistenbüro GbR
Gender Notice. The personal designations used in this text always refer equally to female, male and diverse persons. Double/triple naming and gendered designations are used for better readability. ected.
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