FDA Approves Elotuzumab for the Treatment of Multiple Myeloma
It is approved in combination with lenalidomide and dexamethasone
On 30 November, 2015 the US Food and Drug Administration (FDA) granted approval for elotuzumab (Empliciti) in combination with two other therapies to treat patients with multiple myeloma who have received one to three prior medications.
“We are continuing to learn about the ways the immune system interacts with different types of cancer, including multiple myeloma," said Dr Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. Elotuzumab is the second monoclonal antibody approved to treat patients with multiple myeloma. Daratumumab (Darzalex), approved in November 2015 is the only other FDA-approved monoclonal antibody for the treatment of patients with multiple myeloma.
Elotuzumab is a humanized IgG1 monoclonal antibody targeted against Signaling Lymphocyte Activation Molecule (SLAMF7, also called CS1), a glycoprotein expressed on myeloma and Natural Killer cells, but not detectable in normal tissue. 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 lenalidomide (Revlimid) and dexamethasone).
The safety and efficacy of Empliciti were tested in a randomised, open-label clinical ELOQUENT-2 study of 646 participants whose multiple myeloma progressed after, or did not respond to previous treatment. Those receiving Empliciti plus Revlimid and dexamethasone experienced a progression-free survival of 19.4 months compared to participants receiving only Revlimid and dexamethasone (14.9 months). Additionally, 78.5% of those treated with Empliciti with Revlimid and dexamethasone had an overall response rate compared to 65.5% in those only treated with Revlimid and dexamethasone.
The most common side effects of Empliciti are fatigue, diarrhoea, 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. 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 being co-developed with AbbVie, with Bristol-Myers Squibb leading the commercialisation of the agent. It 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.