FDA Grants Priority Review to Multiple Myeloma Drug

Elotuzumab is an immunostimulatory antibody combination therapy for patients who received one or more prior therapies.

Patients with multiple myeloma may soon have a new treatment option available in their fight against cancer.

The FDA on Tuesday granted priority review to the Biologics License Application filed for elotuzumab (Empliciti), an investigational Signaling Lymphocyte Activation Molecule (SLAMF7)-directed immunostimulatory antibody. The drug treats multiple myeloma as a combination therapy for patients who received one or more prior therapies.

Empliciti previously received Breakthrough Therapy Designation by the FDA and was granted accelerated assessment by The European Medicines Agency.

“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, MD, senior vice president and head of the Oncology Development at 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 filing comes on the heels of the recent phase 3 ELOQUENT-2 trial, which was a randomized, open-label study that examined Empliciti in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone.

An additional phase 2, randomized, open-label study evaluated Empliciti with bortezomib and dexamethasone versus bortezomib and dexamethasone alone.

“AbbVie is encouraged by the FDA’s decision to award priority review to this application,” said Gary Gordon, MD, vice president of oncology clinical development at AbbVie. “AbbVie is committed to the development of novel treatment options for people affected by cancer.”