The US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted against the overall benefit–risk profile at the proposed dosage of belantamab mafodotin (blenrep) combinations.
The combinations, bortezomib and dexamethasone and pomalidomide and dexamethasone, were evaluated in adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy in the DREAMM-7 and DREAMM-8 trials.
The committee voted on several questions, including whether safe and effective dosing had been established.
“This is a very challenging decision because the efficacy data were strong but the toxicity data were also very strong,” said Neil Vasan, MD, PhD, of NYU Langone, during the vote. He added that there were “many missed opportunities” in investigating different dosing in patients.
Panelists also cited the lack of US participation in pivotal studies.
“Because of my concern about the percentage of enrollment in the US, the relevance of the control groups, and of course, we all talked about the safety of this drug at the proposed dose,” said Mark Conaway, MD, of the University of Virginia.
In a statement issued after the vote, GSK, the manufacturer of blenrep, said that “it remains confident in the benefit/risk profile of blenrep and will continue to work closely with the FDA.”
The agency is expected to review the committee’s recommendation ahead of the agency’s target date of July 23, 2025.
Listen to the podcast with Drs. Usmani and Lonial on the topic.
