A new immune-stimulating treatment for multiple myeloma has been approved by the US Food and Drug Administration (FDA).
Elotuzumab (Empliciti; Bristol-Myers Squibb) was granted approval in combination with lenalidomide (Revlimid) and the corticosteroid dexamethasone for people who have already received one to three previous medications.
The drug works by activating the immune system to attack and kill multiple myeloma cells.
The FDA decision was based on results from a randomised, open-label clinical study of 646 participants whose multiple myeloma had returned after, or failed to respond to, prior treatment. Those taking elotuzumab plus lenalidomide and dexamethasone had a longer delay until their disease worsened than participants taking only lenalidomide and dexamethasone (19.4 months compared with 14.9 months).
Tumour shrinkage was observed in 78.5% of those taking elotuzumab plus lenalidomide and dexamethasone, versus 65.5% among those taking lenalidomide and dexamethasone.
“We are continuing to learn about the ways the immune system interacts with different types of cancer, including multiple myeloma,” says Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
Elotuzumab is the second monoclonal antibody that the FDA has approved to treat the disease, after daratumumab (Darzalex) was given the green light on 16 November 2015. Ixazomib (Ninlaro), the first oral proteasome inhibitor for multiple myeloma, was approved by the FDA on 20 November 2015.
The application for elotuzumab was given “breakthrough therapy” designation by the FDA, awarded when preliminary clinical evidence for a drug intended to treat a serious condition suggests it may demonstrate “substantial improvement” over available therapies. It was also granted orphan drug designation and priority review status.