GSK PLC on Tuesday said it has started the process to withdraw US marketing authorisation for its cancer drug, Blenrep, on the request of the US Food & Drug Administration.
GSK is a London-based multinational pharmaceutical and biotechnology company. Blenrep, or belantamab mafodotin, is an antibody drug conjugate designed to treat adult patients with relapsed or refractory multiple myeloma.
Blenrep is an anti-BCMA therapy. BCMA, or B-cell maturation antigen, is a cell-surface protein expressed on the membrane of normal and malignant plasma cells, but not other normal tissues. Overexpression leads to the survival of multiple myeloma cells.
The request follows GSK’s previous announcement that the drug had failed to meet its primary endpoint of progression-free survival in phase three trials.
The Dreamm-3 trial, which was designed to evaluate the efficacy of Blenrep compared to Pomdex in patients with relapsed or refractory multiple myeloma patients, did not meet the requirements of the US FDA Accelerated Approval regulations.
Based on all the data from this programme, the company said it still considered the benefit-risk profile of Blenrep to be favourable.
‘We respect the agency’s approach to the accelerated approval regulations and associated process. Multiple myeloma is a challenging disease, with poor outcomes for patients whose disease has become resistant to standard-of-care treatments,’ said GSK Chief Medical Officer Sabine Luik.
‘We will continue the Dreamm clinical trial programme and work with the US FDA on a path forward for this important treatment option for patients with multiple myeloma.’
Patients already involved in the Blenrep Risk Evaluation & Mitigation Strategy programme will have the option to enrol in a compassionate-use programme to continue to access treatment.
GSK warned that patients currently being treated with Blenrep should consult their healthcare provider.
Data from further trials, including results from the Dreamm-7 and Dreamm-8 Phase 3 trials, are expected in the first half of 2023.
GSK shares were trading 1.0% higher at 1,412.20 pence each in London on Tuesday morning.
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