Halozyme Announces FDA Accepted BLA for Fixed-Dose Subcutaneous Perjeta, Herceptin Combination

Halozyme Therapeutics announced the U.S. Food and Drug Administration has accepted a Biologics License Application (BLA) from Genentech, a member of the Roche Group, for the 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 for the treatment of eligible patients with HER2-positive breast cancer.

"The acceptance of our partner's BLA submission is an important development for our ENHANZE® technology platform," said Dr. Helen Torley, president and chief executive officer. "This will represent the first product utilizing ENHANZE® that combines two biologics, Perjeta and Herceptin, in one fixed-dose, subcutaneous administration. We are excited that patients with HER2-positive breast cancer may now benefit from a shorter treatment administration option."

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

Subcutaneous administration of the fixed-dose combination of Perjeta and Herceptin is approximately eight minutes for the initial loading dose and approximately five minutes for each subsequent maintenance dose. Intravenous administration is approximately 150 minutes for the loading dose of Perjeta and Herceptin using standard IV formulations and between 60-150 minutes for subsequent maintenance infusions for the combination.

Halozyme's proprietary ENHANZE® drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE® may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.

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