The Food and Drug Administration on Thursday delivered a split decision on a blood cancer drug from GSK, approving its use in one combination regimen but rejecting another.
The mixed ruling is the latest twist in the turbulent history of the multiple myeloma drug, called Blenrep.
GSK had submitted different Blenrep combinations to the FDA as treatments for patients with the disease who had already tried at least one other therapy, with one regimen being tested in the DREAMM-7 trial and the other in the DREAMM-8 study. Both studies showed Blenrep helped cut the risk of disease progression or death, and DREAMM-7 also demonstrated a benefit on overall survival.
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