LONDON (Reuters) – An independent panel to the U.S. Food and Drug Administration on Tuesday voted in favor of approving GlaxoSmithKline’s 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 and Genmab’s 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.
(Reporting by Alistair Smout in London; Editing by Arun Koyyur)
