FDA approves a new immune-stimulating drug to treat multiple myeloma

December 2, 2015

FDA has approved elotuzumab (Empliciti, Bristol-Myers Squibb and AbbVie) for the treatment of multiple myeloma.

FDA has approved elotuzumab (Empliciti, Bristol-Myers Squibb and AbbVie) as combination therapy with lenalidomide (Revlimid, Celgene) and dexamethasone (ERd) in people with multiple myeloma who have received 1 to 3 prior medications.

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Multiple myeloma is a hematologic cancer that forms in plasma cells, a type of white blood cell found in the bone marrow that produces antibodies to help fight infections. In multiple myeloma, these cancerous cells produce abnormal proteins, accumulate in the bone marrow and crowd out healthy blood cells. This may result in symptoms such as bone pain, fatigue, kidney impairment, and infections.

Empliciti is an immunostimulatory antibody that targets Signaling Lymphocyte Activation Molecule Family member 7 (SLAMF7), a glycoprotein located on the cell surface of myeloma cells. Empliciti not only activates the immune system through plasma cells via the SLAMF7 pathway, but also tags the malignant cells for destruction via antibody-dependent cellular toxicity. Empliciti is approved in combination with Revlimid (lenalidomide), another FDA-approved treatment for multiple myeloma, as well as dexamethasone in patients who have received one to three prior therapies.

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“Multiple myeloma remains largely incurable, with only half of patients surviving five years after diagnosis,” said Sagar Lonial, MD, chief medical officer of the Winship Cancer Institute of Emory University. “The approval of elotuzumab (Empliciti) provides renewed hope for the multiple myeloma community who urgently need a treatment option that extends the time patients live without their disease progressing.”

The safety and efficacy of Empliciti were demonstrated in a randomized, open-label clinical study of 646 participants whose multiple myeloma relapsed, or did not respond to previous treatment. Those patients taking Empliciti along with dexamethasone and Revlimid experienced an average delay in the time before their disease worsened of 19.4 months compared to 14.9 months in those taking only Revlimid and dexamethasone. Additionally, 78.5% of patients taking Empliciti saw a complete or partial shrinkage of their tumors compared to 65.5% of those who were not taking the drug.

FDA granted breakthrough therapy designation, priority review, as well as orphan drug designation to Empliciti. The most common side effects associated with the use of Empliciti include fatigue, diarrhea, fever, constipation, cough, peripheral neuropathy, and nasopharyngitis. 

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