FDA panel votes in favour of approving GSK's multiple myeloma drug
Reuters
Published Jul 14, 2020 21:25
LONDON (Reuters) - An independent panel to the U.S. Food and Drug Administration on Tuesday voted in favour of approving GlaxoSmithKline's (L:GSK) 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 (N:JNJ) and Genmab 's (CO:GMAB) 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.
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Written By: Reuters
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