Bristol-Myers Squibb Company BMY announced that the FDA has accepted the supplemental Biologics License Application (sBLA) seeking label expansion of multiple myeloma drug, Empliciti (elotuzumab). The sBLA seeks approval of Empliciti in combination with Celgene’s CELG Pomalyst (pomalidomide) and low-dose dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma (r/rMM) in second- or later-line settings.

The sBLA was granted priority review by the FDA. A decision is expected on Dec 27, 2018.

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.

Shares of Bristol-Myers have declined 1.9% year to date versus the industry’s increase of 5.2%

The sBLA included data from phase II study – ELOQUENT-3 – which evaluated the Empliciti combination regimen in patients who have received at least two prior therapies or whose disease has relapsed or is resistant to Revlimid and a proteasome inhibitor.

Data from the study showed that patients treated with Empliciti plus Pomalyst and dexamethasone (EPd) had a 46% reduction in risk of disease progression compared to patients receiving only Pomalyst and dexamethasone (Pd). The progression free survival (“PFS”) in EPd arm was 10.3 months compared with 4.7 months in the Pd arm.

Bristol-Myers commercializes Empliciti in collaboration with AbbVie ABBV. The drug generated sales of $119 million in the first half of 2018. However, the combination therapy, if approved, can 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 largest cancer drug, Opdivo, continues to excel and expand in new indications and geographies. In June, Opdivo received approval as the first PD-1 inhibitor in China for the treatment of locally advanced or metastatic non-small cell lung cancer after prior platinum-based chemotherapy in adult patients without EGFR or ALK genomic tumor aberrations. However, the drug faces stiff competition globally from Merck’s MRK PD-L1 inhibitor, Keytruda.

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