GlaxoSmithKline PLC (LON:GSK) announced the US Food and Drug Administration (FDA) advisory committee unanimously agreed the benefits of its multiple myeloma candidate outweigh the risks.
Multiple myeloma is a common blood cancer that is generally considered treatable but not curable. After a while, treatments tend to stop working, which is why companies are trying to come up with new drugs.
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The belantamab mafodotin antibody achieved a “clinically meaningful” overall response rate in the DREAMM trial, which enrolled patients who had already been treated and saw their condition worsening despite receiving the current standard of care.
The FDA will consider the recommendation of the committee but is not obligated to follow it, though it granted breakthrough therapy designation to belantamab mafodotin in 2018 and priority review earlier to its biologics licence application this year.
The investigational antibody is not approved for use anywhere in the world.
The drug is efficacious but causes an eye side-effect that can impair vision, analysts at Liberum noted, but said it will almost certainly gain approval soon after the committee's approval.
“This is an important project in GSK's efforts to rejuvenate its research and development and build a new oncology division. We have peak sales of £3.8bn for this product underlining its importance,” the broker commented.
Shares rose 2% to 1,628.33p on Wednesday at the opening bell.