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FDA顾问投票反对批准血癌药物，葛兰素史克倒闭
2025-07-18 01:29
- A group of independent advisors to the U.S. Food and Drug Administration (FDA) on Thursday voted against the approval of a combination drug regimen involving GSK’s (NYSE:GSK) blood cancer medicine Blenrep.
- The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 5-3 against the benefit-risk profile of Blenrep in combination with bortezomib and dexamethasone for relapsed/refractory multiple myeloma as a late-line therapy.
- The panelists voted 7-1 against the drug’s benefit-risk profile with pomalidomide and dexamethasone for the same indication.
- The British pharmaceutical company's Biologics License Application targeted at getting U.S. approval for the combination drug for R/R multiple myeloma as a late-line therapy is currently under FDA review with a target action date of July 23.
- The FDA's advisory committees issue non-binding recommendations. However, the regulator generally follows them before making a final decision on authorizations.
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