NEW BRUNSWICK (dpa-AFX) - Johnson & Johnson EMEA, a worldwide leader in multiple myeloma, announced Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommends the approval of an indication extension of TALVEY (talquetamab).
The recommendation is for talquetamab plus daratumumab with or without pomalidomide for the treatment of adults with relapsed or refractory multiple myeloma (RRMM), who have received at least one prior therapy.
The CHMP recommendation is based on Phase 3 results where talquetamab and daratumumab, with or without pomalidomide, showed progression-free survival of up to 81% and overall survival of up to 89% at 24 months.
If approved, TALVEY plus daratumumab will be the only GPRC5D-targeting bispecific antibody combination therapy for relapsed or refractory second-line multiple myeloma treatment.
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