GSK

FDA panel votes in favor of approving GSK's multiple myeloma drug

Credit: REUTERS/MATTHEW CHILDS

LONDON, July 14 (Reuters) - An independent panel to the U.S. Food and Drug Administration on Tuesday voted in favor of approving GlaxoSmithKline's GSK.L experimental treatment for a common form of blood cancer, saying the benefits of the treatment outweigh the risks.

Approval for belantamab mafodotin as a treatment for multiple myeloma is seen as important for GSK's growing oncology portfolio. The drug is a rival to Johnson & Johnson JNJ.N and Genmab's GMAB.CO Darzalex treatment.

The FDA will now make a final decision on the treatment. While the agency is not bound to follow the recommendation of its advisory panel, it usually does.

The FDA had on Friday raised safety concerns over how the treatment can cause deposits to gather on the cornea, known as keratopathy.

GSK had said it was confident in the benefit/risk profile of the drug, and proposed that it should be managed through modifying or interrupting the course of treatment.

UPDATE 1-FDA unclear if benefits of GSK multiple myeloma drug outweigh risks

(Reporting by Alistair Smout in London; Editing by Arun Koyyur)

((alistair.smout@thomsonreuters.com; +44 207 542 7064; Reuters Messaging: alistair.smout.thomsonreuters.com@reuters.net))

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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