Bristol-Myers Squibb Co.(BMY) and AbbVie (ABBV) said Monday that elotuzumab, an investigational drug in combination with lenalidomide and low-dose dexamethasone, was granted the Breakthrough Therapy Designation by the U.S. Food and Drug Administration or FDA, for the treatment of multiple myeloma in patients who have received one or more prior therapies.
The designation was conferred, based on findings from a randomized Phase 2, open-label study which assessed two dose levels of elotuzumab in combination with lenalidomide and low-dose dexamethasone in previously-treated patients, including the 10 mg/kg dose that is being studied in Phase 3 trials.
According to the FDA, Breakthrough Therapy Designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for Breakthrough Therapy Designation require preliminary clinical evidence that shows the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.
For comments and feedback: editorial@rttnews.com