FDA approves 3rd multiple myeloma med in a month, this time from Bristol-Myers & AbbVie
- The FDA has approved Empliciti (elotuzumab), an immunologic cancer treatment for multiple myeloma. It is intended to be used in combination with Celgene's Revlimid (lenalidomide).
- This is the second FDA-approved monoclonal antibody for the treatment of multiple myeloma, the third multiple myeloma med approved in November, and the fourth approved this year.
- The approval is based on the strength of ELOQUENT-2 trial data, which included 646 patients with refractory or non-responsive multiple myeloma.
The data were sufficiently compelling to justify an FDA approval. Overall, combining Empliciti with lenalidomide and dexamethasone resulted in 19.4 months of progression-free survival (PFS), compared with 14.9 months of PFS in patients treated with the standard combination therapy. In addition, overall response rates in the Empliciti-treated group were 78.5% versus 60.1% in the control.
Empliciti's target is a cell-surface protein known as SLAM7. Development of this therapy represents another step forward for immuno-oncology. BMS and AbbVie not only received breakthrough therapy designation, but were given an approval three months ahead of the PDUFA date.
In terms of the larger market, Empliciti is joining the recently approved Darzalex from Johnson & Johnson, as well as Takeda's Ninlaro. With this approval, BMS continues to shore up its position as a front-runner in the immuno-oncology race—with Opdivo as its superstar. At the same time, AbbVie is building a stronger presence in immuno-oncology by positioning itself through acquisitions and partnerships.
All told, experts expect the immuno-oncology sector to eventually generate $30 billion per year in revenues.