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FDA Approves Empliciti to Treat Multiple Myeloma
The FDA has approved elotuzumab (Empliciti, Bristol-Myers Squibb) in combination with two other therapies to treat people with multiple myeloma who have received one to three prior medications.
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. 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.
“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 the 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), approved earlier this month, is the only other FDA-approved monoclonal antibody for the treatment of patients with multiple myeloma.
Elotuzumab activates the body’s immune system to attack and kill multiple myeloma cells. It is approved in combination with another FDA-approved treatment for multiple myeloma called lenalidomide (Revlimid, Celgene) and dexamethasone (a type of corticosteroid).
The safety and efficacy of elotuzumab were tested in a randomized, open-label clinical study of 646 participants whose multiple myeloma came back after or did not respond to previous treatment. Those taking elotuzumab plus lenalidomide and dexamethasone experienced a delay in the amount of time before their disease worsened (19.4 months) compared to participants taking only lenalidomide and dexamethasone (14.9 months). Additionally, 78.5% of those taking elotuzumab with lenalidomide and dexamethasone saw a complete or partial shrinkage of their tumors, compared to 65.5% in those taking lenalidomide and dexamethasone.
The most common side effects of elotuzumab are fatigue, diarrhea, pyrexia, constipation, cough, peripheral neuropathy, nasopharyngitis, upper respiratory tract infection, decreased appetite, and pneumonia.
The FDA granted breakthrough therapy designation for this application, which is granted when a drug is intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies on one or more clinically significant endpoints.
Elotuzumab also received priority review and orphan drug designations. Priority review status is granted to applications for drugs that, if approved, would be a significant improvement in safety or effectiveness in the treatment of a serious condition. Orphan drug designation provides incentives such as tax credits, user fee waivers, and eligibility for orphan drug exclusivity to assist and encourage the development of drugs for rare diseases.
Source: FDA, December 1, 2015.