U.S. FDA Approves Blenrep for Relapsed/Refractory Multiple Myeloma

The U.S. Food and Drug Administration (FDA) has approved belantamab mafodotin-blmf (Blenrep, GSK) in combination with bortezomib (Velcade, Takeda) and dexamethasone for relapsed or refractory multiple myeloma. This combination is known as BVd. This approval applies to adult patients who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.

The approval was based on the phase 3 DREAMM-7 clinical trial. The results of this clinical trial showed that the Blenrep combination lowered the risk of death and helped patients live longer without their cancer growing or changing. These patients had a 51% lower risk of death. The median progression-free survival for those treated with the Blenrep combination was 31.3 months compared to 10.4 months for those who received standard of care.

Blenrep has been a lifesaving drug for many patients who have few treatment options. “With the approval of Blenrep, we now have a community-accessible BCMA-targeting agent with the potential to improve outcomes for patients following two or more prior lines of treatment, where options are limited. This approval marks an important advance in the US relapsed/refractory treatment landscape,” said Sagar Lonial, MD of the Winship Cancer Institute in Atlanta, Georgia. 

How does Blenrep treat multiple myeloma?

Blenrep is an antibody-drug conjugate (ADC). It combines a monoclonal antibody that targets the B-cell maturation agent (BCMA), which is a protein found on myeloma cells, with a chemotherapy agent. The monoclonal antibody directs the cancer destroying chemotherapy directly to the myeloma cells. 

Blenrep’s journey to FDA approval

This is the second approval for Blenrep in the US. The drug first received accelerated approval for patients with relapsed or refractory myeloma after four prior lines of therapy in August 2020. This approval was based on the DREAMM-2 clinical trial.

After its approval, new side effects affecting the eyes were identified, including dry eyes and blurry vision. When the DREAMM-3 clinical trial confirming the benefit of Blenrep did not show enough of an improvement in progression-free survival over the standard of care, GSK voluntarily pulled Blenrep from the market in 2022.

Ongoing DREAMM-7 and DREAMM-8 clinical trials have showed lasting improvements for many patients treated with Blenrep in combination with other drugs. Based on these results, Blenrep was approved in the European Union, United Kingdom, Canada, Switzerland, and Brazil. However, Blenrep’s approval was uncertain in the U.S. following an FDA Oncologic Drugs Advisory Committee (ODAC) meeting in July. 

This FDA approval covers Blenrep in combination with BVd, but does not include the other combination of Blenrep with pomalidomide and dexamethasone, also known as BPd.

New REMS program monitors patient safety and long-term clinical trials are ongoing

Blenrep is now available in the United States through a new, streamlined REMS program that will monitor patient safety. The new REMS program includes simplified patient forms and will continue to monitor side effects. 

The DREAMM-7 and DREAMM-8 clinical trials are ongoing to monitor the long-term results for people treated with Blenrep. 

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