EMA Advisory Committee Recommends AbbVie’s and BMS’ Cancer Drug

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that Bristol-Myers Squibb’s and AbbVie’s Empliciti (elotuzumab), an investigational immunostimulatory antibody, be granted approval for the treatment of multiple myeloma as combination therapy with Revlimid (lenalidomide) and dexamethasone in patients who have received at least one prior therapy. The application now will be reviewed by the European Commission, which has the authority to approve medicines for the European Union (EU).

Bristol-Myers Squibb and AbbVie are co-developing Empliciti, with Bristol-Myers Squibb solely responsible for commercial activities. In November 2015, the US Food and Drug Administration approved Empliciti in combination with lenalidomide and dexamethasone in patients with multiple myeloma who have received one to three prior therapies.

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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