GSK’s Blenrep Approved for Multiple Myeloma

The FDA has approved GlaxoSmithKline’s Blenrep (belantamab mafodotin-blmf) for the treatment of adults with elapsed or refractory multiple myeloma who have received at least four prior therapies.

The accelerated approval was based on a phase 2 trial in which Blenrep demonstrated an overall response rate of 31 percent, with 73 percent of the responses lasting more than six months.

The agency noted the risk of ocular toxicity and said continued approval of Blenrep may depend on results from confirmatory trials.