BMS, AbbVie land Breakthrough label
Bristol-Myers Squibb and AbbVie pocketed a Breakthrough Therapy designation for the experimental multiple myeloma medication elotuzumab.
The companies announced the expedited FDA review classification of their monoclonal antibody Monday. The experimental drug is being investigated for use in tandem with lenalidomide and dexamethasone for patients who have already received at least one or two rounds of prior therapy.
The companies said the FDA handed over the label based on open-label Phase-II data.
BMS and AbbVie are co-developing the drug, and BMS is taking the lead on its commercialization.