FDA Approves Empliciti, a New Immune-Stimulating Therapy to Treat Multiple Myeloma

Web Exclusives - FDA Approvals, In the News

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 60.1 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.

US Food and Drug Administration. FDA approves Empliciti, a new immune-stimulating therapy to treat multiple myeloma. Updated November 30, 2015.

Related Items
FDA Approves Polivy in Combination with Bendamustine plus rituximab for Patients with Relapsed, Refractory DLBCL
TON - August 2019, Vol 12, No 4 published on August 6, 2019 in FDA Approvals
Xpovio plus Dexamethasone Combination Receives Accelerated Approval for the Treatment of Patients with Relapsed or Refractory MM
TON - August 2019, Vol 12, No 4 published on August 6, 2019 in FDA Approvals
FDA News
TOP - August 2019, Vol 12, No 3 published on July 29, 2019 in FDA Approvals
Keytruda Approved for Patients with Previously Treated Metastatic Small-Cell Lung Cancer
Yvette Florio Lane
Web Exclusives published on June 26, 2019 in FDA Approvals, In the News
First Chemoimmunotherapy Regimen Granted Accelerated Approval for Patients with Previously Treated DLBCL
Yvette Florio Lane
Web Exclusives published on June 12, 2019 in FDA Approvals, In the News
Welcome to the Fourth Annual Oncology Guide to New FDA Approvals
2019 Fourth Annual Oncology Guide to New FDA Approvals published on June 5, 2019 in FDA Approvals
New Indications Approved by the FDA in 2018 for Oncology Drugs
Dalia Buffery, MA, ABD
2019 Fourth Annual Oncology Guide to New FDA Approvals published on June 5, 2019 in FDA Approvals
FDA Approvals of Novel Brand-Name Prescription Cancer Drugs in 2018
2019 Fourth Annual Oncology Guide to New FDA Approvals published on June 5, 2019 in FDA Approvals
Braftovi (Encorafenib) plus Mektovi (Binimetinib) Third BRAF/MEK Inhibition Combination Approved for Metastatic Melanoma with BRAF Mutation
Lisa A. Raedler, PhD, RPh, Medical Writer
2019 Fourth Annual Oncology Guide to New FDA Approvals published on June 5, 2019 in FDA Approvals, Melanoma
Copiktra (Duvelisib) Approved for Relapsed or Refractory CLL, SLL, and Follicular Lymphoma
Lisa A. Raedler, PhD, RPh, Medical Writer
2019 Fourth Annual Oncology Guide to New FDA Approvals published on June 5, 2019 in FDA Approvals, Lymphoma
Last modified: February 19, 2019