Bristol-Myers Squibb and AbbVie have announced that the US Food and Drug Administration (FDA) has approved the use of Empliciti in combination with Revlimid® and dexamethasone (ERd) as a treatment for relapsed myeloma patients who have received between one to three previous lines of treatment. The approval is based on data from the Phase III ELOQUENT-2 trial which demonstrated that ERd significantly increased progression free survival (PFS) compared to Rd alone (19.4 mths vs 14.9 mths respectively). Empliciti becomes the second monoclonal antibody to be approved by the FDA as a treatment for myeloma following the recent approval of Darzalex® (daratumumab). It is currently being assessed by the European Medicines Agency (EMA) where a decision is expected soon.

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