Biotechnology company Halozyme Therapeutics Inc (NASDAQ:HALO) said on Monday that it has filed its Biologics License Application (BLA), for the fixed-dose combination of pertuzumab (Perjeta) and trastuzumab (Herceptin) using its ENHANZE drug delivery technology, with the US Food and Drug Administration for the treatment of HER2-positive breast cancer.

The company has filed the BLA for its partner, Genentech, a member of the Roche Group.

Genentech's fixed-dose combination of pertuzumab (Perjeta) and trastuzumab (Herceptin) for subcutaneous administration using Halozyme's ENHANZE drug delivery technology in combination with intravenous (IV) chemotherapy is an important development for the treatment of eligible patients with HER2-positive breast cancer with the US Food and Drug Administration.

Additionally, the BLA submission is based on positive results from Genentech's global Phase III FeDeriCa study, which demonstrated non-inferior levels of Perjeta in the blood and comparable efficacy and safety to standard IV infusions of Perjeta plus Herceptin and chemotherapy.

Halozyme's proprietary ENHANZE drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20), which has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously.