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Bristol-Myers' Empliciti Gets EMA Nod for Label Expansion

Zacks Equity Research

Bristol-Myers Squibb Company BMY announced that the European Medicines Agency ("EMA") has approved the label expansion of Empliciti in combination with Celgene’s CELG Pomalyst (pomalidomide) and low-dose dexamethasone (EPd) for the treatment of relapsed and refractory multiple myeloma (r/rMM) in third or later-line settings. Patients should have received at least two prior therapies including Revlimid and a proteasome inhibitor and demonstrated disease progression on the last therapy.

The approval was based on data from the phase II ELOQUENT-3 study, which showed that treatment with EPd combination reduced the risk of disease progression by 46% compared to dexamethasone alone, which is the current standard-of-care in Europe for r/rMM. Updated data presented in June 2018 from an exploratory analysis of ELOQUENT-3 study showed that 67% were alive in EPd arm compared to 51% for the comparator arm.

A similar label expansion for Empliciti was approved by the FDA in November last year. Please note that Bristol-Myers is developing the drug in collaboration with AbbVie ABBV while it is solely responsible for commercial activities related to the drug.

Shares of Bristol-Myers have declined 2.1% year to date compared with the industry’s decrease of 7.8%.


Empliciti is also approved in combination with Celgene’s Revlimid for treatment of r/rMM in patients who have received one to three prior therapies. The company is developing this combination for first-line multiple myeloma.

The drug generated sales of $174 million in the first half of 2019. Approval of the combination therapy will provide an important treatment option for European patients with relapsed/refractory multiple myeloma whose disease has progressed after treatment with lenalidomide and a proteasome inhibitor.

Meanwhile, the company’s blockbuster immuno-oncology drug, Opdivo continues to perform well, driven by label expansions. However, the drug faces stiff competition globally from Merck’s MRK PD-L1 inhibitor, Keytruda.

Bristol-Myers Squibb Company Price


Bristol-Myers Squibb Company Price

Bristol-Myers Squibb Company price | Bristol-Myers Squibb Company Quote

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Bristol-Myers currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

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