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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 ...
CURE4h
FDA Votes Against Proposed Blenrep Treatment Combo’s for Multiple Myeloma
The FDA's Oncologic Drugs Advisory Committee has casted their votes on the utilization of certain treatments in the multiple ...
pharmaphorum11h
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, ...
Healio4h
‘Surprising’ setback: ODAC rebuffs Blenrep for multiple myeloma, citing ocular toxicity
An FDA advisory committee ruled in two separate votes that two belantamab mafodotin combination regimens should not be used ...
BioSpace7h
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 ...
STAT4h
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 Pharma3d
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 ...
The Pharma Letter2d
FDA probes ocular toxicity of Blenrep as GSK seeks new indications
UK pharma major GSK is seeking US approval for Blenrep (belantamab mafodotin) in two multiple myeloma indications.