Bristol-Myers Squibb’s drug elotuzumab has been granted priority review by the FDA as a combination therapy for the treatment of blood cancer.
The decision means that elotuzumab has taken a big step towards US approval, as regulators will now review its marketing application in just six months.
If the drug is approved, BMS plans to market it under the brand name Empliciti.
The FDA’s decision to expedite its review process comes on the back of early data in the Eloquent-2 clinical trial involving 646 patients published in The New England Journal of Medicine.
The results showed that adding elotuzumab to treatment with Celgene’s Revlimid (lenalidomide) and dexamethasone cut the risk of the disease progressing by 30% and additionally extended remission by over four months.
The drug was also evaluated in a phase II trial that showed adding elotuzumab to Johnson and Johnson’s Velcade (bortezomib) and dexamethasone improved median progression free survival rates by nearly three months.
Michael Giordano, senior VP and head of oncology development at BMS, said: “Bristol-Myers Squibb is delighted by the approach both agencies have taken to review the Empliciti applications as it underscores the unmet medical need in the treatment of multiple myeloma.”
BMS is co-developing elotuzumab with AbbVie, but their collaboration sees BMS solely responsible for all commercial activities.
Elotuzumab was designated ‘breakthrough’ drug by the FDA last year, which is designed to accelerate development and review of treatments for life-threatening conditions.
Analysts have suggested the drug could reach $300m peak sales. The myeloma market was valued at $7.3bn in 2014 and is set to expand to just under $9bn by 2021.
Despite various advances in multiple myeloma treatment, the disease is largely incurable and only 45% of patients survive past five years after diagnosis.