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FDA Approves Elotuzumab Plus Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma


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ON NOVEMBER 6, 2018, following Priority Review, the U.S. Food and Drug Administration (FDA) approved elotuzumab (Empliciti) injection for intravenous use in combination with pomalidomide (Pomalyst) and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide (Revlimid) and a proteasome inhibitor.

The approved dose of elotuzumab when used in combination with pomalidomide and dexamethasone is 10 mg/kg administered intravenously every week for the first two 28-day cycles. Thereafter, elotuzumab is administered at 20 mg/kg every 4 weeks until disease progression or unacceptable toxicity.

In ELOQUENT-3, a randomized, open-label, phase II trial, elotuzumab plus pomalidomide and dexamethasone demonstrated benefit in patients with relapsed or refractory multiple myeloma, doubling both median progression-free survival and overall response rate vs pomalidomide and dexamethasone.

Key Findings of ELOQUENT-3

RESULTS FROM the ELOQUENT-3 trial, which were presented at the 23rd Congress of the European Hematology Association in June 2018, included the following findings:

Elotuzumab plus pomalidomide and dexamethasone reduced the risk of disease progression by 46% (hazard ratio [HR] = 0.54; 95% confidence interval [CI] = 0.34–0.86, P = .0078), demonstrating a median progression-free survival of 10.25 months (95% CI = 5.59– nonestimable) vs 4.67 months (95% CI = 2.83–7.16) for pomalidomide and dexamethasone alone after a minimum follow-up of 9.1 months.

Response rates doubled in patients receiving elotuzumab plus pomalidomide and dexamethasone (53.3% [95% CI = 40.0%–66.3%]) compared with patients receiving pomalidomide and dexamethasone alone (26.3% [95% CI = 15.5%–39.7%]; P = .0029), with very good partial responses or better seen in 20% of patients treated with elotuzumab plus pomalidomide and dexamethasone (n = 12) and 8.8% of patients treated with pomalidomide and dexamethasone.

Serious adverse reactions were reported in 22% of patients treated with elotuzumab plus pomalidomide and dexamethasone and in 15% of patients treated with pomalidomide and dexamethasone.

Elotuzumab with pomalidomide and dexamethasone is associated with warnings and precautions related to infusion reactions, infections, secondary primary malignancies, hepatotoxicity, interference with determination of complete response, pregnancy, and reproductive potential. ■


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