Bristol-Myers Squibb Company (BMY - Free Report) announced that the European Medicines Agency (EMA) has validated its type II variation application, seeking approval for Empliciti in combination with Celgene Corporation’s (CELG - Free Report) Pomalyst and low-dose dexamethasone (EPd), for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including Revlimid and a proteasome inhibitor (PI), and have demonstrated disease progression on the last therapy.
The validation by the EMA confirms that the submission is complete and consequently EMA can begin its centralized review process.
The application was based on data from the phase II study, ELOQUENT-3, evaluating the EPd combination versus Pomalyst and dexamethasone (Pd) alone in patients with relapsed or refractory multiple myeloma (RRMM).
We note that Bristol-Myers is co-developing Empliciti, with AbbVie, Inc. (ABBV - Free Report) . Per the agreement, the company is solely responsible for commercial activities.
Empliciti is already approved in combination with Celgene’s Revlimid (lenalidomide) and dexamethasone for the treatment of multiple myeloma in patients who have received one to three prior therapies.
In August 2018, the FDA accepted the company’s supplemental Biologics License Application (sBLA) seeking label expansion of Empliciti. The sBLA seeks approval of Empliciti in combination with Pomalyst and low-dose dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma (r/rMM) who have received at least two prior therapies. The FDA granted the application priority review with an action date of Dec 27, 2018.
Shares of Bristol-Myers have declined 0.5% year to date versus the industry’s increase of 5.1%.
The drug generated sales of $119 million in the first half of 2018. However, the combination therapy, if approved, will provide an important treatment option for 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 currently has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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