Pharmaceutical giants Bristol-Myers Squibb Company and AbbVie announced the US Food and Drug Administration (FDA) has accepted their Biologics License Application (BLA) for Empliciti (elotuzumab), an investigational Signaling Lymphocyte Activation Molecule (SLAMF7)-directed immunostimulatory antibody, indicated for the treatment of multiple myeloma in combination with other traditional therapies.
Recently, the drug was granted a Breakthrough Therapy Designation, which will significantly accelerate its development process and regulatory review. The European Medicines Agency (EMA) also recently accepted the Marketing Authorization Application for Empliciti, effectively granting it accelerated review. If approved by these health authorities, Empliciti will serve as the drug’s brand name.
“Bristol-Myers Squibb is delighted by the approach both agencies have taken to review the Empliciti applications as it underscores the unmet medical need in the treatment of multiple myeloma and the role Immuno-Oncology may play,” said Michael Giordano, M.D., senior vice president, Head of Oncology Development, Bristol-Myers Squibb. “The acceptance of our applications by the FDA and EMA brings Bristol-Myers Squibb’s Immuno-Oncology science a step closer to helping patients with hematologic malignancies.”
The FDA based its acceptance of the two companies’ BLA on the favorable results of the ELOQUENT-2 study, which was a Phase 3, randomized, open-label study assessing Empliciti when administered with lenalidomide and dexamethasone, compared to the treatment with lenalidomide and dexamethasone alone. The results of this study were published in The New England Journal of Medicine on June 2.
The BLA was also backed by findings from CA204-009, a Phase 2, randomized, open-label study that aimed to evaluate Empliciti together with bortezomib and dexamethasone, against treatment with bortezomib and dexamethasone alone. These findings were presented during an oral session (Abstract #S103) at the 20th Congress of the European Hematology Association (EHA).
“AbbVie is encouraged by the FDA’s decision to award priority review to this application,” said Gary Gordon, M.D., vice president, oncology clinical development, AbbVie. “AbbVie is committed to the development of novel treatment options for people affected by cancer.”
Bavituximab is a chimeric monoclonal antibody developed to target the protein phosphatidylserine (PS), which masks tumor cells and inhibits their recognition by the immune system. Bavituximab binds to PS, therefore blocking it along with its immunosuppressive action, enhancing anti-tumor immune responses.
