Roche has secured the US Food and Drug Administration (FDA) approval for Phesgo, a fixed-dose subcutaneous (SC) injection, for use combination with intravenous (IV) chemotherapy to treat early and metastatic HER2-positive breast cancer.

Phesgo is a combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase, administered as SC injection. It is the first time for the Swiss drugmaker to combine two monoclonal antibodies, administered by a single SC injection.

Roche chief medical officer and global product development head Levi Garraway said: “The FDA approval of Phesgo reflects our commitment to improving outcomes for the many people living with HER2-positive breast cancer.

“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.”

FDA approved Phesgo based on results from the Phase 3 FeDeriCa trial

Phesgo has been developed by leveraging Halozyme Therapeutics’ Enhanze drug delivery technology and can be administered by a healthcare professional in a treatment centre or at a patient’s home

The FDA approval of Phesgo is based on results from the Phase 3 FeDeriCa study, an international, multi-centre, two-arm, randomised, open-label clinical trial that evaluated the pharmacokinetics, efficacy and safety of subcutaneous injection of Phesgo in combination with chemotherapy.

The study compared Phesgo plus chemotherapy to standard intravenous (IV) infusions of Perjeta and Herceptin plus chemotherapy, in 500 people with HER2-positive early breast cancer.

Phase 3 FeDeriCa trial has met its primary endpoint showing non-inferior levels of Perjeta in the blood during a given dosing interval (Ctrough), compared to IV administration of Perjeta.

The study also reached the secondary endpoints of non-inferior levels of Herceptin, with blood concentrations for people receiving the fixed-dose combination non-inferior to those receiving IV Herceptin.

Phesgo plus chemotherapy showed a comparable safety profile with IV administration of Perjeta plus Herceptin and chemotherapy, and no new safety signals were identified. The most common adverse events include alopecia, nausea, diarrhoea and anaemia.

Furthermore, Phase 2PHranceSCa trial, randomised, multi-centre, multinational, open-label, cross-over study showed that 85% of people receiving HER2-positive breast cancer treatment preferred treatment under the skin to IV administration, said the company