FDA Grants Breakthrough Therapy Designation To Bristol-Myers Squibb's, AbbVie's Elotuzumab
By Cyndi Root
Bristol-Myers Squibb Company (BMS) and AbbVie announced in a press release that the Food and Drug Administration (FDA) has granted elotuzumab a Breakthrough Therapy Designation. The investigational humanized monoclonal antibody is for use in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in patients who have received one or more prior therapies. BMS and AbbVie are co-developing the drug, and BMS will market the drug if it is approved. The FDA granted the breakthrough status, in part, based on Phase II studies, the results of which were presented at the 18th Annual Congress of the European Hematology Association (EHA).
Michael Giordano, SVP, Head of Development, Oncology & Immunosciences at Bristol-Myers Squibb, 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.”
Elotuzumab
Elotuzumab is a humanized IgG1 monoclonal antibody. It targets a glycoprotein, Signaling Lymphocyte Activation Molecule (SLAMF7, also called CS1). Investigators believe that elotuzumab targets SLAMF7 expressing myeloma cells. The drug is also being studied in monotherapy trials for smoldering myeloma. In combination treatment studies with bortezomib and dexamethasone, the agent shows promise in treating relapsed or refractory multiple myeloma. Phase III trials are proceeding under the titles ELOQUENT-1 for multiple myeloma and ELOQUENT-2 for relapsed or refractory multiple myeloma.
Clinical Trials
The FDA’s Breakthrough Designation expedites the development of elotuzumab, since multiple myeloma is a significant unmet need. The designation means that the FDA acknowledged that elotuzumab demonstrated substantial improvement in at least one primary measure compared to an available therapy. A Phase II study evaluated two doses of elotuzumab in combination with lenalidomide and low-dose dexamethasone in previously treated patients. Investigators reported that the 10 mg/kg dose group achieved a median progression-free survival (PFS) of 33 months. In the 20 mg/kg dose group, patients’ median PFS was 18 months. BMS intends to use the 10 mg/kg dose in the next trial.
Multiple Myeloma
Multiple myeloma is a hematologic cancer. It begins in the bone marrow and progresses. The second most common blood cancer, there is no cure yet. BMS estimates that about 25,000 new cases are found each year in the U.S.