US regulators have approved Roche's Phesgo, a fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase, for the treatment of early and metastatic HER2-positive breast cancer.

The therapy, which is administered in combination with intravenous (IV) chemotherapy, marks the first time that Roche has combined two monoclonal antibodies that can be administered by a single SC injection.

Administration of Phesgo can take around eight minutes for the initial loading dose and approximately five minutes for each subsequent maintenance dose, compared to 150 minutes for a sequential 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.

The Swiss drugs giant also noted that Phesgo can be administered by a healthcare professional in a treatment centre or at a patient’s home.

“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,” said Levi Garraway, Roche's chief medical officer and Head of Global Product Development.

Approval of Phesgo is based on data from the Phase III FeDeriCa study, which met its primary endpoint with the drug showing non-inferior levels of Perjeta in the blood during a given dosing interval (Ctrough), when compared to IV administration of Perjeta.

The safety profile of Phesgo with chemotherapy was comparable to IV administration of Perjeta plus Herceptin and chemotherapy, and no new safety signals were identified, Roche stressed.