Breakthrough designation for B-MS/AbbVie’s MM drug elotuzumab

The US Food and Drug Administration has granted elotuzumab, an investigational humanized monoclonal antibody under development by Bristol-Myers Squibb (NYSE: BMY) and AbbVie (NYSE: ABBV), Breakthrough Therapy designation for use in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in patients who have received one or more prior therapies.

The designation, intended to expedite the development and review of drugs for serious or life-threatening conditions, is based on findings from a randomized Phase II, open-label study that evaluated 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 III trials. Data from the Phase II trial were most recently presented at the 18th Annual Congress of the European Hematology Association (EHA) last year (The Pharma Letter June 16, 2013).

“Despite recent advances in the treatment of relapsed or refractory multiple myeloma, it remains an area of unmet need,” said Michael Giordano, senior vice president, head of development, Oncology & Immunosciences, at B-MS, adding: “This Breakthrough Therapy Designation underscores the potential of elotuzumab in this setting and reinforces Bristol-Myers Squibb’s longstanding commitment to the research and development of novel medicines to treat hematologic malignancies.”