FDA OKs BMS’ and AbbVie’s Multiple Myeloma Drug

The US Food and Drug Administration (FDA) has approved Empliciti (elotuzumab) by Bristol-Myers Squibb and AbbVie for treating multiple myeloma as a combination therapy with Revlimid (lenalidomide) and dexamethasone in patients who have received one to three prior therapies. Empliciti is also under review by the European Medicines Agency and has been granted accelerated assessment.

Bristol-Myers Squibb and AbbVie are co-developing Empliciti, with Bristol-Myers Squibb solely responsible for commercial activities. Prior to approval, Empliciti was granted breakthrough therapy designation by the FDA for use in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in patients who have received one to three prior therapies. According to the FDA, breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for breakthrough therapy designation requires preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.

Empliciti is an immunostimulatory antibody that specifically targets Signaling Lymphocyte Activation Molecule Family member 7 (SLAMF7), a cell-surface glycoprotein. SLAMF7 is expressed on myeloma cells independent of cytogenetic abnormalities. SLAMF7 is also expressed on natural killer cells, plasma cells, and at lower levels on specific immune cell subsets of differentiated cells within the hematopoietic lineage.

Empliciti has a dual mechanism-of-action. It directly activates the immune system through natural killer cells via the SLAMF7 pathway. Empliciti also targets SLAMF7 on myeloma cells, tagging these malignant cells for natural killer cell-mediated destruction via antibody-dependent cellular toxicity.

Source: Bristol-Myers Squibb 

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