GSK’s Blenrep: 15 Days From Confirmatory Trial Failure To Withdrawal Announcement
The first BCMA-targeting agent to gain approval in myeloma never became the blockbuster for which GSK had hoped, but Blenrep appears to have set a new standard for speed of voluntary withdrawal of an accelerated approval drug after a confirmatory trial failure.
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AstraZeneca’s Lynparza: US FDA Frowns Upon ‘All Comers’ Indication In First-Line Prostate Cancer
Efficacy in PROpel study was driven by the small percentage of patients with tumor BRCA mutations, agency says, raising concerns that olaparib may amount to a ‘toxic placebo’ in those without the mutation; Oncology Drugs Advisory Committee will consider whether new indication in metastatic castration-resistant prostate cancer should be restricted by mutation status.
The ODAC Losing Streak Ends
US FDA’s Oncologic Drugs Advisory Committee’s endorsement of a first-line indication for Genentech’s Polivy is the first time the panel has voted ‘yes’ on a cancer drug application in almost three years.
The Long And Short Of Accelerated Approval Accountability In US
The latest accelerated approval withdrawals in the US are milestones for accountability in the program – most notably with the withdrawal of an antimicrobial with confirmatory studies more than a decade overdue.