FDA rejects overall benefit/risk profile of GSK's blood cancer drug dosage
By Iain Gilbert
Date: Friday 18 Jul 2025
(Sharecast News) - Drugmaker GSK said on Friday that the US Food and Drug Administration's Oncologic Drugs Advisory Committee had voted against the overall benefit/risk profile of its relapsed/refractory multiple myeloma asset at the proposed dosage.
GSK said the FDA will consider the recommendation of the committee as it finalises its review on its Blenrep asset in advance of the 23 July PDUFA date and noted that it "remains confident" in the benefit/risk profile of the drug.
The FTSE 100-listed firm added that the belantamab mafodotin combinations were evaluated in adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.
GSK also said it will continue to work closely with the FDA as it completes its review for Blenrep in patients with relapsed or refractory multiple myeloma, where GSK said there was "high unmet need" for novel treatment options that extend survival.
AJ Bell's Dan Coatsworth said: "A troubling £3.8bn has been wiped off the value of GSK after the US drug regulator cast doubt over its blood cancer drug, Blenrep, being approved for use. The FDA has voted against the proposed dosage from a benefit/risk perspective. It means the likelihood of Blenrep's approval next week is looking extremely slim.
"There is always a high risk with drug developments and pharmaceutical companies are no strangers to setbacks. However, Blenrep was particularly important to GSK, with analysts forecasting peak annual sales in the region of £2.9bn and the drug had one of the highest probabilities of approval in its pipeline. This situation, along with the prospect of new tariffs on drugs imported into the US, means GSK is suddenly on the sick bed. GSK has lost nearly a tenth of its market value in the past eight days, which is worrying for a company of its stature."
Reporting by Iain Gilbert at Sharecast.com
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