IQWiG (German HTA) · January 05, 2026

IQWiG assessment: linvoseltamab for relapsed or refractory multiple myeloma – unmet evidence need

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

IQWiG notes linvoseltamab received conditional marketing authorisation in April 2025 but comparative evidence is lacking until 2026.

Low obligation Product class Pharmaceuticals Market Access & Reimbursement Germany PharmaceuticalsHealth technology assessment

Linvoseltamab is another bispecific antibody now available, but the results of a comparative study are not expected until 2026. Numerous drugs are available for the treatment of multiple myeloma. What is lacking is comparative evidence – so there is more of 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.

Dates and deadlines

Regulatory Deadline

December 31, 2026

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Published by IQWiG (German HTA). HealthSignal links to the original document; the summary above is extracted from the source text.