Going Virtual: GSK’s Multiple Myeloma Drug Belantamab Tapped For US FDA Online AdComm In July
Announcement of the 14 July Oncologic Drugs Advisory Committee meeting follows a successful, two-day trial run of the virtual format by the oncology pediatric subcommittee that featured a mix of prerecorded and live sponsor presentations and strict adherence to a call/response approach to ensure orderly conduct.
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Agency has created a centralized team to help review divisions with virtual advisory committee preparations and is trying to notify sponsors earlier in the review process about the need for a panel; sponsors cite importance of having a back channel of communications so team members can communicate with each other while an AdComm is underway.
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.
Syndax CEO also says US FDA’s virtual meetings would benefit from having advisory committee members on camera, which may be a technology challenge.