FDA approves Empliciti to treat 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.