British pharma juggernaut GSK announced this week that it’s begun the process to withdraw the U.S. marketing authorization for its multiple myeloma monotherapy, Blenrep, as requested by the FDA.
Blenrep — an antibody targeting B-cel maturation antigens — was approved in 2020 for patients who had received at least four other rounds of unsuccessful treatment for multiple myeloma. The accelerated approval hinged on data from GSK’s DREAMM-2 trial, which showed Blenrep doses resulted in anti-myeloma activity with a manageable safety profile.
But the approval was also contingent on a confirmed clinical benefit from a randomized phase 3 clinical trial, the DREAMM-3 trial, in which the drug did not meet its primary endpoint of progression-free survival. Now, the FDA is taking back its green light.
In order to support patients who are already enrolled in the Blenrep Risk Evaluation and Mitigation Strategy (REMS) and receiving treatment, GSK is creating a ‘compassionate’ program that will allow them to continue having access to the drug for the time being. As for future steps, GSK’s Chief Medical Officer Sabine Luik said, “We will continue the DREAMM clinical trial program and work with the U.S. FDA on a path forward for this important treatment option for patients with multiple myeloma.”
