FDA approves first immunostimulatory antibody for multiple myeloma

FDA approved elotuzumab (Empliciti, Bristol-Myers Squibb and AbbVie) for the treatment of multiple myeloma as combination therapy with lenalidomide (Revlimid, Celgene) and dexamethasone (ERd) in people with multiple myeloma who have received one to three prior medications.

Related: Oncology drugs in the pipeline

Empliciti activates the body’s immune system to attack and kill multiple myeloma cells.

Multiple myeloma is a form of blood cancer that occurs in infection-fighting plasma cells (a type of white blood cell) found in the bone marrow. These cancerous cells multiply, produce an abnormal protein and push out other healthy blood cells from the bone marrow. This disease may result in a weakened immune system, and cause other bone and kidney problems, according to an FDA press release. The National Cancer Institute estimates there will be 26,850 new cases of multiple myeloma and 11,240 related deaths in the United States this year.   

The approval of this first and only immunostimulatory antibody for multiple myeloma is based on data from the randomized, open-label, phase 3, ELOQUENT-2 study of 646 participants, which demonstrated that the ERd regimen resulted in a 30% reduction in the risk of disease progression or death compared to Rd alone (HR 0.70 [95% CI: 0.57, 0.85; P=0.0004]). Those taking Empliciti plus Revlimid and dexamethasone experienced a delay in the amount of time before their disease worsened (19.4 months) compared to participants taking only Revlimid and dexamethasone (14.9 months). Additionally, 78.5% of those taking Empliciti with Revlimid and dexamethasone saw a complete or partial shrinkage of their tumors compared to 65.5% in those only taking Revlimid and dexamethasone.

Giordano

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