FDA Extends Review Period for Blenrep (belantamab mafodotin) for Relapsed or Refractory Myeloma 

July 23, 2025—According to a press release from GSK, "the US Food and Drug Administration (FDA) has extended the review period for the Biologics License Application (BLA) for Blenrep (belantamab mafodotin-blmf) combinations for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. The new Prescription Drug User Fee Act (PDUFA) action date is October 23, 2025, and provides the FDA with time to review additional information provided in support of the application."

The BLA is based on positive results from the phase III DREAMM-7 and DREAMM-8 trials, which showed that Blenrep combinations significantly improved progression-free survival compared to standard triplet regimens, and overall survival in one trial. Safety findings were consistent with known profiles of the individual drugs.

Blenrep combinations are already approved in several countries, including the UK, Japan, Canada, Switzerland, and the UAE, and are under review in other major markets. GSK remains confident in the therapy’s potential and continues to work closely with the FDA. To learn more, read the full GSK press release from the button below.