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Empliciti (elotuzumab) granted regulatory approval for Multiple Myeloma

New treatment options for Multiple Myeloma

Empliciti (elotuzumab) was granted regulatory approval from the U.S. Food and Drug Administration (FDA) for adults suffering with multiple myeloma who have received at least two therapies in the past. Empliciti, an intravenous treatment, in combination with dexamethasone and pomalidomid as the third-line medication, is a product of Bristol-Myers Squibb.

Empliciti, in combination with the other medications, is intended to be used if other treatments including lenalidomide and a proteasome inhibitor have not been effective in meeting the treatment goals of the patient. USFDA approval was based on results from the Phase II ELOQUENT-3 trial that clearly demonstrated that the drug imparted clinical benefits to the patients with relapsed or refractory multiple myeloma. The clinical data demonstrated clinical edge of Empliciti in its ability to double the median progression-free survival and overall response rate versus pomalidomide and dexamethasone.

In the Phase II trial, Empliciti (in combination with the other two medications) was able to lower down the risk of disease progression by a staggering 46%. Joseph Eid, head of medical division at BMS, expressed that Empliciti can help extending the time a patient can live without having his or her disease further deteriorated. The approval of Empliciti is timely and reinforces the stellar potential of immuno-oncology in blood cancers.

Complete report can be read here