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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,
The anemia treatment missed its main goal in a myelofibrosis study. Meanwhile, Blenrep's return to the U.S. market may have ...
In a surprise, a FDA advisory panel voted that risks tied to a GSK blood cancer drug called Blenrep outweighed the benefits ...
The panelists flagged safety concerns with Blenrep and GSK’s failure to optimize its dosing regimen for the antibody-drug ...
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 ...
GSK has been enjoying regulatory momentum in recent months as it works to bring its antibody-drug conjugate (ADC) Blenrep ...
Asianet Newsable on MSN12h
GSK’s Blenrep Underwhelms FDA Panel Over Dose Risk-Benefit Balance In Myeloma; Retail Traders Stay OptimisticThe median progression-free survival was 32.6 months on the Blenrep combo compared to 12.5 months on the alternative. While ...
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