Less than five months after posting positive top-line data, Bristol-Myers Squibb and AbbVie have scored a new combo win for Empliciti.
Tuesday, the FDA greenlighted the multiple myeloma immunotherapy, in combination with Celgene’s Pomalyst and dexamethasone, to treat patients who’ve relapsed or proved resistant to treatment after receiving at least two prior treatments, including Celgene’s Revlimid and a proteasome inhibitor.
The quick go-ahead comes a few months after U.S. regulators tagged the regimen, known as EPd for short, with their breakthrough designation, setting it up for a decision by Dec. 27. The reason? Phase 2 results showing that EPd could slash the risk of myeloma progression by 46%, compared with Pomalyst and dexamethasone on their own.
Bristol, a leader in the immuno-oncology field, was quick to point to “the importance of immuno-oncology in blood cancers,” as Joseph Eid, M.D., Bristol SVP and head of medical, said in a statement. The approval gave “healthcare professionals an effective new tool to tackle this relentless cancer,” he added.
It also gave Bristol, which handles commercialization for the product sans AbbVie, another avenue for sales. Empliciti generated $119 million through the year’s first half, marking an increase of just $11 million over its haul from the same period in 2017.
The new nod is the first label expansion for Empliciti since it hit the scene in 2015 as part of a combo containing Revlimid and dexamethasone, meant for patients who have received between one and three prior myeloma treatments. Johnson & Johnson’s Darzalex, by contrast—which debuted around the same time—has since picked up a slew of new nods, including a historic OK in newly diagnosed patients.