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.
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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.
“Empliciti represents a fundamentally different treatment approach for patients that delivered improved outcomes that were maintained over time,” says Michael Giordano, senior vice president, head of development, oncology, Bristol-Myers Squibb. “An important aspect of the maintained benefit, is the reduction of deaths [19% fewer deaths] in the Empliciti arm versus the control arm.”
Paul G. Richardson, MD, from Dana-Farber Cancer Institute will present extended follow-up and overall survival data from ELOQUENT-2 on Saturday, December 5, 8:15-8:30 a.m., during the 57th Annual Meeting & Exposition of the American Society of Hematology (ASH) in Orlando, Florida.
Diarrhea, fever (pyrexia), constipation, cough, nerve damage resulting in weakness or numbness in the hands and feet, infection of the nose and throat, upper respiratory tract infection, decreased appetite and pneumonia are the most common side effects of Empliciti.
FDA granted breakthrough therapy designation for this application. Empliciti also received priority review and orphan drug designations.
The drug is available for injection for intravenous use in 300-mg and 400-mg vials.
“We are continuing to learn about the ways the immune system interacts with different types of cancer, including multiple myeloma," said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research. “Today’s approval is the second monoclonal antibody approved to treat patients with multiple myeloma and works with another approved therapy to provide additional benefit."
Daratumumab (Darzalex, Janssen Biotech) was approved earlier this month and is the only other FDA-approved monoclonal antibody for the treatment of patients with multiple myeloma.