BMS and AbbVie receive FDA breakthrough therapy designation for elotuzumab, an investigational humanized monoclonal antibody for multiple myeloma.
Bristol-Myers Squibb and AbbVie reported that FDA has granted elotuzumab, an investigational humanized monoclonal antibody, breakthrough therapy designation for use in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in patients who have received one or more prior therapies. The designation is based on findings from a randomized Phase 2, open-label study that evaluated two dose levels of elotuzumab in combination with lenalidomide and low-dose dexamethasone in previously-treated patients, including the 10 mg/kg dose that is being studied in Phase 3 trials.
