Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Bristol-Myers Squibb (BMS) and AbbVie have received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for elotuzumab, an investigational humanized monoclonal antibody, to treat multiple myeloma.
Subscribe to our email newsletter
Elotuzumab is being co-developed with AbbVie, while BMS is leading the commercialization of the agent.
The drug was granted this designation for use in combination with lenalidomide and dexamethasone to treat multiple myeloma in patients who have received one or more prior therapies.
The breakthrough therapy designation is based on data from a randomized, open-label Phase II that 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 III trials.
BMS senior vice president and head of Development, Oncology & 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 longstanding commitment to the research and development of novel medicines to treat hematologic malignancies," Giordano said.
The company said that elotuzumab is targeted against Signaling Lymphocyte Activation Molecule (SLAMF7, also called CS1), a glycoprotein expressed on myeloma and Natural Killer cells but not detectable in normal tissue.