15th Jul 2020 06:31
(Alliance News) - GlaxoSmithKline PLC late on Tuesday said its Belantamab Mafodotin cancer medication received a vote of confidence from an advisory board to the US Food & Drug Administration.
GSK added however, that the nod from FDA's Oncologic Drugs Advisory Committee does not guarantee regulatory approval.
The company said 12 of 14 committee members voted in favour of the "demonstrated benefit" of Belantamab to treat relapsed or refractory multiple myeloma - a cancer that forms in the white blood cells - outweighing its risks. The remaining two members of the committee were unable to make the final vote.
"The FDA will consider the recommendation of the committee but is not obligated to follow it. The FDA granted breakthrough therapy designation to belantamab mafodotin in 2017 and priority review designation for the biologics license application earlier this year," GSK said.
The drug is currently not approved for use anywhere in the world, the company noted.
By Eric Cunha; [email protected]
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