US-based pharmaceutical firms Bristol-Myers Squibb (BMS) and AbbVie have received breakthrough therapy designation from the US Food and Drug Administration (FDA) for elotuzumab, an investigational humanised monoclonal antibody, for treatment of multiple myeloma.
Elotuzumab was granted breakthrough therapy status for use in combination with lenalidomide and dexamethasone to treat multiple myeloma in patients who have received one or more prior therapies.
Breakthrough therapy status is based on data from a randomised, open-label Phase II that evaluated two dose levels of elotuzumab in combination with lenalidomide and low-dose dexamethasone in previously treated patients, including the 10mg/kg dose that is being studied in Phase III trials.
Bristol-Myers Squibb senior vice-president and head of development, oncology and immunosciences Michael Giordano said despite recent advances in the treatment of relapsed or refractory multiple myeloma, it remains an area of unmet need.
"This breakthrough therapy designation underscores the potential of elotuzumab in this setting and reinforces Bristol-Myers Squibb’s long-standing commitment to the research and development of novel medicines to treat hematologic malignancies," Giordano said.
Elotuzumab is targeted against signalling lymphocyte activation molecule (SLAMF7, also called CS1), a glycoprotein expressed on myeloma and natural killer cells but not detectable in normal tissue.
Currently, BMS is investigating whether through both direct activation and engagement of natural killer cells, elotuzumab may selectively target and kill SLAMF7 expressing myeloma cells.
At present, elotuzumab is being studied as a monotherapy in smoldering myeloma and in combination with other therapies in first-line and relapsed or refractory multiple myeloma.
A clinical development programme for elotuzumab is underway, including Phase III trials in first-line multiple myeloma (ELOQUENT-1) and relapsed or refractory multiple myeloma (ELOQUENT-2).
The agent is also being investigated in a randomised Phase II trial of bortezomib and dexamethasone in relapsed or refractory multiple myeloma.
Elotuzumab is being co-developed with AbbVie, while BMS is leading the commercialisation of the agent.