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

Credit: REUTERS/MATTHEW CHILDS

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.

Adds GSK's statement, background

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.

"We are committed to working closely with the FDA to complete the review of belantamab mafodotin for these patients who have limited treatment options," a GSK spokesperson said.

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.

In its mid-stage study DREAMM-2, nearly 100 patients were given the drug at the dosage for which GSK has submitted for approval.

Of them, 31% showed a meaningful response to the treatment, indicating its efficacy, but 27% experienced medically severe keratopathy. One patient discontinued treatment due to the side-effect but no patients experienced life threatening symptoms.

GSK's experimental treatment belongs to a promising class of drugs called antibody-drug conjugates (ADC) and poses a challenge to the dominance of J&J-Genmad owned Darzalex with its approval.

ADCs link powerful cell toxins to antibodies that cling to cancer cells, sparing the healthy cells that are damaged during conventional chemotherapy treatments.

Belantamab mafodotin targets the BCMA protein in cells characteristic of multiple myeloma - an area of focus for many drugmakers.

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

(Reporting by Alistair Smout in London and additional reporting by Aishwarya Venugopal in Bengaluru; 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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