FDA Grants Bristol-Myers Squibb & AbbVie’s Elotuzumab Breakthrough Status

US regulatory body, the Food and Drug Administration (FDA), have granted breakthrough therapy status to Bristol-Myers Squibb and AbbVie’s elotuzumab to treat multiple myeloma (MM).

The designation has been granted by the FDA for elotuzumab’s use with lenalidomide and dexamethasone in patients who have previously received one or more therapies to treat multiple myeloma.

Elotuzumab is a humanised IgG1 monoclonal antibody targeted against Signaling Lymphocyte Activation Molecule (SLAMF7, also called CS1), a glycoprotein expressed on myeloma and natural killer cells but not detectable in normal tissue.

The decision by the regulatory body was based on a Phase II clinical study, which showed that the triple combo offered significant benefit in progression-free survival (33 months) for patients with multiple myeloma.

Breakthrough designation involves more intensive guidance from the regulatory agency on putting together an efficient drug development programme.  The criteria to receive FDA breakthrough status requires preliminary clinical data which demonstrates that the drug could offer a substantial improvement, over treatment currently available, for at least one clinically significant endpoint.

Bristol-Myers Squibb’s head of oncology and immunosciences development, Michael Giordano, commented that “despite recent advances in the treatment of relapsed or refractory MM, it remains an area of unmet need.”  Giordano added that receiving the breakthrough status from the FDA “underscores the potential of elotuzumab in this setting.”

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