Posted by Michael Wonder on 05 Oct 2023
Orphan drug for multiple myeloma: G-BA must formally certify legally assumed additional benefit
5 October 2023 - Due to legal requirements, the Federal Joint Committee (G-BA) has completed the re-evaluation process for belantamab mafodotin and had to certify an additional benefit, although confirmation of approval of the drug is currently uncertain.
The EMA had already recommended not to extend the approval of the active ingredient, which was originally subject to certain conditions. However, the final decision from the European Commission is currently missing. The G-BA therefore had to complete the procedure for reassessing the additional benefit and, for formal reasons, certified that the active ingredient had an unquantifiable additional benefit.
