FDA has granted priority review for GlaxoSmithKline’s Biologics License Application seeking approval of belantamab mafodotin for patients with relapsed or refractory multiple myeloma whose prior therapy included an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.
A group of melanoma experts, joined by three advocacy groups focused on melanoma, has engaged FDA in a public discussion of the challenges of developing new drugs in the refractory setting and the role crossover can play in such trials.
