The designation is based on findings from a Phase II study that evaluated two dose levels of elotuzumab in combination with lenalidomide and low-dose dexamethasone in previously-treated MM patients.
The FDA Breakthrough Designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria require preliminary clinical evidence that demonstrates substantial improvement on at least one endpoint over available therapies.
“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, BMS. “This Breakthrough Therapy Designation underscores the potential of elotuzumab in this setting and reinforces Bristol-Myers Squibb’s longstanding commitment to the R&D of novel medicines to treat hematologic malignancies.”