The FDA postponed its decision to October 23 on GSK’s Blenrep for multiple myeloma following a negative recommendation from the Oncologic Drugs Advisory Committee. The delay allows additional review of new data submitted by GSK supporting the drug’s use in combination therapies for previously treated multiple myeloma patients. Safety concerns cited include high rates of ocular toxicity and dose modifications in pivotal DREAMM trials. The advisory panel also questioned trial demographics due to low U.S. patient enrollment. Blenrep was initially approved in 2020 but withdrawn globally after a failed confirmatory trial. The extension offers GSK more time to potentially address the FDA’s benefit-risk concerns.