New GSK WKN: A3DMB5 ISIN: GB00BN7SWP63 Kürzel: GS71 Forum: Aktien User: o2kuh

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. Shares of the British pharma giant lost ~5% in reaction. 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. Bortezomib and pomalidomide are FDA-approved cancer drugs marketed by Johnson & Johnson (JNJ) and Bristol Myers (BMY) as Velcade and Pomalyst, respectively. Dexamethasone is a widely used anti-inflammatory agent. The London-based drugmaker'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.

GSK falls as FDA advisors vote against approving blood cancer drug

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