GSK's antibody-drug conjugate Blenrep, intended for relapsed/refractory multiple myeloma, faces regulatory uncertainty as the FDA questions sufficiency of data supporting its market re-entry. An Oncologic Drugs Advisory Committee meeting scheduled for mid-July will deliberate on benefit-risk profiles of Blenrep in combination regimens, following its voluntary withdrawal in late 2022 after confirmatory trials failed to meet endpoints. Bridging EMA's recent recommendation in the EU, the FDA's deliberations will assess safety concerns including ocular toxicity. This development highlights ongoing challenges in re-approvals of accelerated-approval oncology agents after initial setbacks.