FDA Approved for RRMM: Elotuzumab (Empliciti) with Pomalidomide and dexamethasone (Pd)

11/06/2018 : U.S. Food and Drug Administration Approves Empliciti® (elotuzumab) Plus Pomalidomide and Dexamethasone, a New Immunotherapy Combination for Certain Patients with Relapsed or Refractory Multiple Myeloma.

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Empliciti (elotuzumab) injection for intravenous use in combination with pomalidomide and dexamethasone (EPd) for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.

In ELOQUENT-3, a randomized, open-label, Phase 2 trial, EPd demonstrated benefit in patients with relapsed or refractory multiple myeloma, doubling both median progression-free survival (PFS) and overall response rate (ORR) versus pomalidomide and dexamethasone (Pd).

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https://news.bms.com/news/details/2018/US-Food-and-Drug-Administration-Approves-Empliciti-elotuzumab-Plus-Pomalidomide-and-Dexamethasone-a-New-Immunotherapy-Combination-for-Certain-Patients-with-Relapsed-or-Refractory-Multiple-Myeloma/default.aspx

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11/06/2018: FDA Approval

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761035Orig1s008ltr.pdf