The European Medicines Agency (EMA) has accepted for review ’s marketing authorisation application (MAA) for Blenrep (belantamab mafodotin), an antibody-drug conjugate (ADC), to treat relapsed or refractory multiple myeloma (r/r MM). The ADC is intended for use in combination with bortezomib plus dexamethasone (BorDex) or pomalidomide plus dexamethasone (PomDex). The gold standard of business intelligence.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) will now commence the formal review process. The application is supported by interim data from the Phase III DREAMM-7 and DREAMM-8 clinical trials. The DREAMM-7 trial enrolled 494 participants randomised to receive either the Blenrep combination or comparator drugs.
302 participants were part of the DREAMM-8 trial. All had prior exposure to lenalidomide, with a substantial proportion refractory to the drug. Access the most comprehensive Company Profiles on the market, powered by GlobalData.
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However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form The studies showed significant improvements in progression-free survival for Blenrep combinations compared to standard care, meeting primary endpoints. The DREAMM-7 trial assessed Blenrep plus BorDex against daratumuma.