Bristol-Myers, AbbVie net FDA 'breakthrough' for myeloma drug Empliciti

Thanks to a boost from U.S. regulators, Bristol-Myers Squibb and AbbVie’s myeloma drug Empliciti could have a new indication by the end of the year.

Thursday, the FDA handed the companies its priority review designation for an Empliciti combo that also features Celgene’s Pomalyst and low-dose dexamethasone. The cocktail is meant for relapsed and refractory multiple myeloma patients who have received at least two prior treatments, including Celgene’s Revlimid and a proteasome inhibitor.

The agency tagged the regimen based on June data that showed it could cut the risk of myeloma progression by 46% in previously treated myeloma patients, compared with Pomalyst and dexamethasone on their own. And now, the FDA expects to have a decision on it by Dec. 27.

If that decision comes up positive, Empliciti could have its first new nod since the one that helped it enter the myeloma market back in 2015. After launching around the same time as a couple of rivals, BMS and AbbVie have watched as one of those contenders—Johnson & Johnson’s Darzalex—has racked up nod after nod, in May becoming the first-ever monoclonal antibody to snag an FDA green light in newly diagnosed patients.

Of course, more indications mean bigger sales, and that’s exactly what the partners are hoping a new go-ahead can bring for Empliciti. Through the first six months of the year, the drug racked up $119 million—just $11 million more than it did in the same period last year.

The myeloma drug Empliciti is currently approved alongside Revlimid and dexamethasone for patients who have already received anywhere from one to three prior treatments.

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