The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has authorised GSK鈥檚 Blenrep for treating multiple myeloma (MM).
This authorisation is said to be a global first for Blenrep in this treatment setting.
Blenrep, in conjunction with bortezomib and dexamethasone (BVd) is approved for adults who have previously undergone a minimum of one therapy.
Additionally, it is approved as the combination with pomalidomide and dexamethasone (BPd) for those who have previously been treated with lenalidomide, among other therapies.
The MHRA decision is supported by efficacy outcomes from the Phase III DREAMM-7 and DREAMM-8 trials in relapsed or refractory MM, which demonstrated meaningful progression-free survival (PFS) and overall survival (OS) results.
The tolerability and safety profiles of the Blenrep combos align with those of the individual agents involved.
Its combos are being reviewed in 14 nations, including the US, Japan, the European Union, China, Switzerland, and Canada.
GSK oncology, research and development (R&D) global head and senior vice-president Hesham Abdullah said: 鈥淭oday’s approval of Blenrep combinations in the UK is a transformative milestone for patients with MM, a cancer marked by remission and relapse.
鈥淎s the only B-cell maturation antigen (BCMA)-targeted antibody-drug conjugate (ADC) therapy, Blenrep has the potential, supported by robust phase III data, to extend survival and remission versus standard of care and redefine treatment at or after first relapse.鈥�
Blenrep consists of an ADC that features a humanised antibody targeting BCMA, attached to the toxic compound auristatin F through a stable linker.
The technology for the drug-linker combination is obtained under license from Seagen, while the production of the monoclonal antibody leverages POTELLIGENT Technology licensed from Kyowa Kirin Group鈥檚 BioWa.
As the only anti-BCMA ADC in MM, the therapy could be administered in various oncology treatment settings.
Last month, GSK announced that it is partnering with the UK Dementia Research Institute (UK DRI) and Health Data Research UK (HDR UK) to explore if its shingles vaccine, Shingrix, could minimise the dementia risk.
