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LONDON - GSK plc (LSE/NYSE:GSK) announced today the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has authorized Blenrep for use in combination therapies to treat adults with multiple myeloma who have received at least one prior therapy. This marks the first global approval of Blenrep in this treatment setting, with reviews underway in 14 other markets.
The MHRA’s approval was supported by results from the DREAMM-7 and DREAMM-8 phase III trials, which demonstrated significant progression-free survival (PFS) and, in DREAMM-7, overall survival (OS) benefits of Blenrep combinations over standard care. The Blenrep regimens showed nearly tripled median PFS in DREAMM-7 and not yet reached median PFS in DREAMM-8 at the time of analysis.
Blenrep is the only anti-BCMA (B-cell maturation antigen) antibody-drug conjugate (ADC) therapy for multiple myeloma, offering a new mechanism of action for patients at or after relapse. Its combinations can be administered in various oncology settings, potentially redefining treatment at early relapses where effective options are limited.
Dr. Joseph Mikhael, Chief Medical (TASE:BLWV) Officer at the International Myeloma Foundation, highlighted the importance of accessible combination therapies like Blenrep in community settings where many patients are treated, noting their potential to extend remission and survival.
The safety profile of the Blenrep combinations was consistent with the known profiles of the individual agents. Eye-related side effects, a known issue with Blenrep, were generally manageable and led to low treatment discontinuations in the trials.
In the UK, Blenrep is now indicated for use with bortezomib and dexamethasone for patients with at least one prior therapy and with pomalidomide and dexamethasone for patients who have received lenalidomide among other treatments.
The approval of Blenrep in the UK is a significant step for multiple myeloma treatment, with further international approvals anticipated throughout 2025. This development is part of GSK’s broader commitment to advancing oncology treatments, focusing on haematologic malignancies and solid tumours. The information in this article is based on a press release statement.
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