- Under its Priority Review process, the FDA approves elotuzumab, in combination with Celgene's (CELG -1.7%) REVLIMID (lenalidomide) and dexamethasone, for the treatment of patients with multiple myeloma (MM) who have received one to three prior lines of therapy.
- In clinical studies, patients receiving elotuzumab plus REVLIMID and dexamethasone showed a longer period of progression-free survival (19.4 months) compared to those receiving REVLIMID and dexamethasone alone (14.9 months). In addition, 78.5% of patients treated with elotuzumab plus the other two experienced complete or partial shrinkage of their tumors compared to 60.1% of patients who did not receive elotuzumab.
- Orphan Drug- and Breakthrough Therapy-tagged elotuzumab was co-developed by Bristol-Myers Squibb (BMY -0.7%) and AbbVie (ABBV -2.2%). BMY has sole commercialization rights to the product, which will be marketed under the brand name Empliciti.
- Multiple myeloma, a type of blood cancer that occurs in plasma cells, strikes ~27K Americans each year resulting in over 11K deaths.
- Elotuzumab is the second monoclonal antibody cleared by the FDA for MM. It approved Janssen's (JNJ -0.7%) Darzalex (daratumumab) several weeks ago.
- Previously: FDA accepts elotuzumab BLA under Priority Review (Sept. 1)
- Previously: FDA clears J&J's Darzalex for treatment-resistant multiple myeloma (Nov. 16)