Bristol-Myers Squibb and AbbVie’s new drug Empliciti validated for EU review

Bristol-Myers Squibb and AbbVie have announced that their new cancer therapy Empliciti has had its marketing authorisation application validated by the European Medicines Agency.

The regulator has accepted the investigational Signaling Lymphocyte Activation Molecule (SLAMF7)-directed immunostimulatory antibody for review, with its Committee for Medicinal Products for Human Use granting it accelerated assessment status.

Empliciti is designed for the treatment of multiple myeloma as a combination therapy in adult patients who have received one or more prior therapies. Its safety and efficacy have been demonstrated by multiple clinical trials.

Bristol-Myers Squibb and AbbVie are co-developing Empliciti, with Bristol-Myers Squibb solely responsible for commercial activities.

Dr Michael Giordano, senior vice-president and head of oncology development at Bristol-Myers Squibb, said: "The marketing authorisation application validation marks a significant milestone in Bristol-Myers Squibb's mission to advance the science and impact the treatment of haematologic malignancies through our immuno-oncology leadership."

Despite advances in multiple myeloma treatment over the last decade, only 45 percent of patients have a ten-year survival rate, meaning there is strong demand for new therapy options.