Elotuzumab (Empliciti) has been approved as combination therapy for individuals with relapsed or refractory multiple myeloma, the Food and Drug Administration announced Nov. 30.
Elotuzumab’s approval was based on a randomized, open-label clinical trial of 646 individuals with relapsed or refractory multiple myeloma. The multicenter trial compared progression-free survival (PFS) and overall response rate (ORR) for 321 individuals receiving lenalidomide (Revlimid) and dexamethasone to the PFS and ORR for 325 individuals receiving elotuzumab, lenalidomide, and dexamethasone.
For individuals receiving elotuzumab together with lenalidomide and dexamethasone, the median PFS of 19.4 months was significantly longer than the median 14.9 months of PFS seen in those receiving just lenalidomide and dexamethasone. For the elotuzumab-containing arm, the ORR was also significantly greater at 78.5%, compared with an ORR of 65.5% for the arm not receiving elotuzumab.
Slightly more patients in the elotuzumab-containing arm experienced serious adverse events, at 65.4% vs. 56.5% for those not receiving elotuzumab. Of the adverse reactions seen in more than 20% of patients, those that occurred more frequently in patients receiving elotuzumab included fatigue, diarrhea, fever, constipation, cough, peripheral neuropathy, upper respiratory tract infection, decreased appetite, and pneumonia.
Elotuzumab is a monoclonal antibody given intravenously; it can interfere with determination of complete response, and infusion reactions, infections, second primary malignancies, and hepatotoxicity may also occur.
Elotuzumab’s target is the surface antigen signaling lymphocyte activation molecule family 7 (SLAMF7). This protein is present on malignant cells in multiple myeloma and is also present on human immune cells such as natural killer cells and monocytes. The recommended dosing is 10 mg/kg intravenously weekly for 2 weeks, then every 2 weeks until disease progression or unacceptable toxicity occurs. Acetaminophen and histamine1 (H1) and H2 blockade should be given preadministration.
“The approval of elotuzumab marks another important milestone in the treatment of multiple myeloma in a short period of time,” Walter M. Capone, president and CEO of the Multiple Myeloma Research Foundation, said in a statement.
Today’s approval is the third in November for multiple myeloma therapies, following the Nov. 16 approval of the monoclonal antibody daratumumab (Darzalex) and the Nov. 20 approval of the oral proteasome inhibitor ixazomib (Ninlaro).
Elotuzumab received priority review by the FDA as a breakthrough drug and also has orphan drug designation. Elotuzumab will be marketed as Empliciti by Bristol-Myers Squibb.
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