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GSK’s Blenrep faces setback as FDA cancer committee votes against approval
Oncologic Drugs Advisory Committee (ODAC) has voted against the benefit/risk profile of GSK’s Blenrep (belantamab mafodotin) just days before the drug’s Prescription Drug User Fee Act (PDUFA) date. This marks a significant setback for the UK-based pharma company,
In a surprise, a FDA advisory panel voted that risks tied to a GSK blood cancer drug called Blenrep outweighed the benefits ...
The FDA's Oncologic Drugs Advisory Committee has casted their votes on the utilization of certain treatments in the multiple ...
An FDA advisory committee ruled in two separate votes that two belantamab mafodotin combination regimens should not be used in the proposed dosages for previously treated adult patients with ...
The panelists flagged safety concerns with Blenrep and GSK’s failure to optimize its dosing regimen for the antibody-drug ...
GSK has been enjoying regulatory momentum in recent months as it works to bring its antibody-drug conjugate (ADC) Blenrep ...
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