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News

FDA, GSK and Blenrep

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Zacks Investment Research on M… · 1h
FDA Advisory Panel Votes Against Approval of GSK's Blenrep Combo
GSK plc GSK announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted against the overall benefit/risk profile of the Blenrep (belantamab mafodotin-blmf) combination therapy at the proposed dosing regimen.

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Pharmaceutical Technology · 20m
GSK’s Blenrep faces setback as FDA cancer committee votes against approval
 · 8h · on MSN
GSK Blood Cancer Drug Blenrep Fails to Win FDA Panel Support
pharmaphorum
6h
GSK's growth plans dented by Blenrep setback
The panel expressed concerns about the proposed doses of Blenrep (belantamab mafodotin) in GSK's marketing application, ...
BioSpace
3h
GSK’s Blenrep Loses Adcomm Vote, Further Clouding Comeback Bid
The panelists flagged safety concerns with Blenrep and GSK’s failure to optimize its dosing regimen for the antibody-drug ...
STAT
2h
Pharmalittle: We’re reading about a GSK setback, another Sarepta gene therapy death, and more
In a surprise, a FDA advisory panel voted that risks tied to a GSK blood cancer drug called Blenrep outweighed the benefits ...
Fierce Pharma
3d
As GSK eyes Blenrep's US return, FDA flags eye safety concerns ahead of advisory committee meeting
GSK has been enjoying regulatory momentum in recent months as it works to bring its antibody-drug conjugate (ADC) Blenrep ...

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