The submission is intended for using the FreedomEDGE system to subcutaneously deliver pertuzumab/trastuzumab/hyaluronidase-zzxf (PHESGO), a co-formulated therapy for human epidermal growth factor receptor (HER)2-positive breast cancer.

The company aims to broaden the application of the system beyond its current immunoglobulin indications to reach the oncology infusion centre market.