Glaxo edges towards first approval for anti-BCMA mechanism

In a clear indication of the limited options available for patients with relapsed or refractory multiple myeloma an FDA advisory committee yesterday voted 12-0 in favour of approving Glaxosmithkline’s belantamab mafodotin. The nod came despite underwhelming efficacy and the severe ocular toxicity associated with the product. While the committee's thumbs-up could make belantamab the first anti-BCMA approved for rrMM, other contenders, particularly Car-T therapies, have shown much better efficacy, albeit with toxicities of their own. Johnson & Johnson’s JNJ-4528 produced an impressive 100% ORR in similar patient population, admittedly in only a handful of subjects, versus the 31% belantamab showed in the Dreamm-2 trial. And despite a four-month filing delay Bristol Myers Squibb’s ide-cel could also pose serious competition if and when it is approved: the registrational Karmma trial generated a 76% ORR. Unsurprisingly, belantamab’s nod comes with strings: patients must have received at least four prior therapies, while a black box warning will be on the label and a REMS programme implemented. With the adcom hurdle behind it, the next test for belantamab will be whether patients are willing to accept the significant risk to their eyesight. The project's weighty $1.25bn 2026 sales forecast depends on a yes to this question.