The European Medicines Agency鈥檚 (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of GSK鈥檚 Blenrep (belantamab mafodotin) for treating the adult population with relapsed or refractory multiple myeloma (MM).
This recommendation supports the use of Blenrep in conjunction with bortezomib + dexamethasone (BVd) and pomalidomide + dexamethasone (BPd) for those who have undergone a minimum of one previous treatment.
The European Commission鈥檚 (EC) decision for approval is anticipated in the third quarter of this year.
This latest announcement follows the recent approvals of Blenrep combos by regulatory agencies in Japan and the UK.
The pivotal Phase III trials, DREAMM-7 and DREAMM-8, have demonstrated superior efficacy of Blenrep combos, showing meaningful progression-free survival (PFS) and overall survival (OS) results.
The tolerability and safety profiles of the Blenrep combos align with the known profiles of the individual agents involved.
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By GlobalDataAdditionally, the trials indicated that side effects related to the eye that are linked to Blenrep are manageable and reversible with appropriate dose adjustments, leading to low discontinuation rates.
Blenrep, an antibody-drug conjugate (ADC), is under review in global markets, including the US, with a prescription drug user fee act (PDUFA) date set for 23 July 2025.
The ADC has received breakthrough therapy designation in China and is undergoing priority review in Canada and Switzerland.
GSK Oncology research and development (R&D) global head and senior vice-president Hesham Abdullah said: 鈥淏lenrep is well positioned to address the unmet needs of these patients while also providing the benefit of in-office administration in both academic and community treatment settings without complex pre-administration regimens or hospitalisation.鈥�
GSK recently signed a deal to acquire efimosfermin from Boston 天美传媒apps for up to $2bn, a drug poised to enter Phase III trials for liver disease treatment.
