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Bristol-Myers' Empliciti Gets EMA Nod for Label Expansion
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Bristol-Myers Squibb Company (BMY - Free Report) announced that the European Medicines Agency ("EMA") has approved the label expansion of Empliciti in combination with Celgene’s 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 - Free Report) 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 - Free Report) PD-L1 inhibitor, Keytruda.
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Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
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Bristol-Myers' Empliciti Gets EMA Nod for Label Expansion
Bristol-Myers Squibb Company (BMY - Free Report) announced that the European Medicines Agency ("EMA") has approved the label expansion of Empliciti in combination with Celgene’s 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 - Free Report) 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 - Free Report) PD-L1 inhibitor, Keytruda.
Bristol-Myers Squibb Company Price
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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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