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FDA Approves Genentech's Phesgo For HER2-positive Breast Cancer

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The FDA has approved Roche Group's (RHHBY.OB) Phesgo regimen that can be administered subcutaneously in combination with intravenous chemotherapy for the treatment of HER2-positive breast cancer that has spread to other parts of the body and for the treatment of HER2-positive breast cancer at an early stage.

Phesgo is a fixed-dose formulation of approved monoclonal antibodies Perjeta and Herceptin with Halozyme Therapeutics' Enhanze drug delivery technology. This is the first time a product has been approved combining two monoclonal antibodies that can be administered by a single subcutaneous injection utilizing Halozyme's ENHANZE technology.

While the administration of Phesgo takes only eight minutes for the initial loading dose and about five minutes for each subsequent maintenance dose, it takes about 150 minutes for infusion of a loading dose of Perjeta and Herceptin using the standard IV formulations, and between 60-150 minutes for subsequent maintenance infusions of the two medicines.

Commenting on the approval, Levi Garraway, chief medical officer and head of Global Product Development, said, "Phesgo offers a treatment administration that supports the needs and preferences of individual patients, and helps to meet the increasing demand across the healthcare system for faster and more flexible treatment options."

Phesgo sports a boxed warning about potential heart failure, fetal harm and lung toxicity.

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