Silver Spring, MD (Press Release) – Today the U.S. Food and Drug Admin­istra­tion granted ap­prov­al for Empliciti (elo­tuzu­mab) 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, M.D., 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." Darzalex (dara­tu­mu­mab), approved earlier this month, is the only other FDA-approved mono­clonal anti­body for the treat­ment of patients with mul­ti­ple myeloma.

Empliciti 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 Revlimid (lena­lido­mide) and dexa­meth­a­sone (a type of corticosteroid).

The safety and ef­fi­cacy of Empliciti 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 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 per­cent of those taking Empliciti with Revlimid and dexa­meth­a­sone saw a com­plete or partial shrinkage of their tumors com­pared to 65.5 per­cent in those only taking Revlimid and dexa­meth­a­sone.

The most common side effects of Empliciti are fatigue, diarrhea, fever (pyrexia), con­sti­pa­tion, cough, nerve damage re­sult­ing in weakness or numbness in the hands and feet (peripheral neu­rop­athy), in­fec­tion of the nose and throat (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. Empliciti 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.

Empliciti is mar­keted by Bristol-Myers Squibb of New York, New York. Darzalex is mar­keted by Janssen Biotech of Horsham, Pennsylvania. Revlimid is mar­keted by Celgene Corpo­ra­tion, based in Summit, New Jersey.

The FDA, an agency within the U.S. ­De­part­ment of Health and Human Services, pro­tects the pub­lic health by assuring the safety, ef­fec­tiveness, and se­cu­ri­ty of human and veterinary drugs, vaccines and other bio­logical prod­ucts for human use, and med­i­cal devices. The agency also is responsible for the safety and se­cu­ri­ty of our nation’s food supply, cosmetics, dietary supple­ments, prod­ucts that give off electronic radi­a­tion, and for regulating tobacco prod­ucts.

Source: Food and Drug Admin­istra­tion.