US FDA Eyes Ocular Risks With GlaxoSmithKline’s Myeloma Drug Belantamab
Heading into an advisory committee review, agency suggests belantamab’s risks of keratopathy and other ocular issues have not been fully characterized and questions whether the proposed mitigation measures, including dosing modifications, are adequate.
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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.
GlaxoSmithKline Survives Technical Woes To Win US FDA Panel Nod For Belantamab
Benefits of the BCMA-directed antibody-drug conjugate outweigh its ocular risks in heavily pretreated multiple myeloma patients, Oncologic Drugs Advisory Committee says at the conclusion of a virtual meeting beset by technical problems.
Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.