Policy & Regulation
Halozyme submits BLA for fixed-dose subcutaneous combination of Perjeta & Herceptin using ENHANZE technology to treat breast cancer
26 February 2020 -

Biotechnology company Halozyme Therapeutics Inc (NASDAQ:HALO) said on Tuesday that it has successfully filed a Biologics License Application (BLA) for fixed-dose combination of pertuzumab (Perjeta) and trastuzumab (Herceptin) with the US Food and Drug Administration.

The BLA has been initiated by the company's partner Genentech, a member of the Roche Group.

According to Halozyme,the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous administration uses its ENHANZE drug delivery technology in combination with intravenous (IV)chemotherapy for treating eligible patients with HER2-positive breast cancer.

This 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. This delivery has shown to reduce health care practitioner time required for administration and shorten time for drug administration.

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