FDA votes against overall benefit/risk profile of GSK's multiple myeloma candidate at proposed dosage

(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.







Reporting by Iain Gilbert at Sharecast.com