GSK: marketing authorisation from EMA
(CercleFinance.com) - GSK has announced that the European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) for Blenrep (belantamab mafodotin), in combination with bortezomib plus dexamethasone (BorDex) or pomalidomide plus dexamethasone (PomDex), as a treatment for relapsed or refractory multiple myeloma.
The EMA's Committee for Medicinal Products for Human Use (CHMP) will begin the formal review process to make a recommendation to the European Commission regarding this potential authorisation.
Trials have shown significant benefit in terms of progression-free survival and positive trends in overall survival for Blenrep combinations compared to standard therapy.
If approved, Blenrep plus BorDex or PomDex could redefine the treatment landscape for relapsed or refractory multiple myeloma, the group says.
GSK said that today's milestone reinforces Blenrep's potential to redefine outcomes for patients with multiple myeloma at or after the first relapse. We are focused on making Blenrep available to patients as quickly as possible, given the high unmet need and clinically robust effects of Blenrep combinations in the Phase III DREAMM-7 and DREAMM-8 trials.
Copyright (c) 2024 CercleFinance.com. All rights reserved.
The EMA's Committee for Medicinal Products for Human Use (CHMP) will begin the formal review process to make a recommendation to the European Commission regarding this potential authorisation.
Trials have shown significant benefit in terms of progression-free survival and positive trends in overall survival for Blenrep combinations compared to standard therapy.
If approved, Blenrep plus BorDex or PomDex could redefine the treatment landscape for relapsed or refractory multiple myeloma, the group says.
GSK said that today's milestone reinforces Blenrep's potential to redefine outcomes for patients with multiple myeloma at or after the first relapse. We are focused on making Blenrep available to patients as quickly as possible, given the high unmet need and clinically robust effects of Blenrep combinations in the Phase III DREAMM-7 and DREAMM-8 trials.
Copyright (c) 2024 CercleFinance.com. All rights reserved.