Bristol-Myers Squibb Company and AbbVie today announced the European Medicines Agency (EMA) validated for review the Marketing Authorization Application (MAA) for Empliciti, an investigational Signaling Lymphocyte Activation Molecule (SLAMF7)-directed immunostimulatory antibody, for the treatment of multiple myeloma as combination therapy in adult patients who have received one or more prior therapies. The application was granted accelerated assessment by the EMA’s Committee for Medicinal Products for Human Use (CHMP).

Bristol-Myers Squibb and AbbVie are co-developing Empliciti, with Bristol-Myers Squibb solely responsible for commercial activities. Bristol-Myers Squibb has proposed the name Empliciti which, if approved by health authorities, will serve as the trade name for elotuzumab.

“The MAA validation marks a significant milestone in Bristol-Myers Squibb’s mission to advance the science and impact the treatment of hematologic malignancies through our Immuno-Oncology leadership,” said Michael Giordano, MD, senior vice president, head of Oncology Development, Bristol-Myers Squibb. “We believe the CHMP’s acceptance for an accelerated assessment reflects the need for a new treatment option for multiple myeloma, a largely incurable disease. We are proud to be one step closer to bringing Empliciti to patients with relapsed or refractory multiple myeloma in Europe.”

For more details, go to: http://news.bms.com/press-release/european-medicines-agency-validates-and-grants-accelerated-assessment-marketing-author