The European Medicines Agency said Friday that the Committee for Medicinal Products for Human Use recommended granting conditional marketing approval of GlaxoSmithKline's Blenrep (belantamab mafodotin) to treat adults with relapsed and refractory multiple myeloma who no longer respond to treatment with an immunomodulatory agent, a proteasome inhibitor and a CD-38 monoclonal antibody. The agency noted that the BCMA-directed antibody-drug conjugate (ADC), which was accepted as part of its PRIME scheme, would be the first ADC in Europe for multiple myeloma patients with limited treatment options.
Earlier this month, an FDA advisory panel voted 12 to 0 that the benefits of belantamab mafodotin outweigh the risks for the proposed patient population with relapsed or refractory multiple myeloma. Prior to that, FDA staff reviewers had highlighted higher rates of ocular toxicity seen among treated patients in the pivotal DREAMM-2 trial, where the overall incidence of keratopathy was 71%, while 44% of subjects suffered at least one severe episode.
GlaxoSmithKline has said corneal changes are a known class-effect of BCMA-directed ADCs and can be managed with dose adjustments, but that they do not appear to cause permanent damage. However, the FDA argued that this depends on the problem being caught early, and as more than half of the patients did not display ocular symptoms, keratopathy could potentially go undetected. For related analysis, see ViewPoints: GSK navigates first hurdle for belantamab mafodotin.
With regard to the corneal risks associated with Blenrep, the EMA indicated that patients would need to undergo specific ophthalmic examinations so that any findings can be managed in time. Meanwhile, the agency said that GlaxoSmithKline will have to submit results of a randomised confirmatory Phase III trial comparing Blenrep with Bristol Myers Squibb's Pomalyst (pomalidomide) plus low-dose dexamethasone, the standard treatment option for relapsed and refractory multiple myeloma. The UK drugmaker is also required to submit final results of the DREAMM-2 study.
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