Roche has secured approval from the US Food and Drug Administration (FDA) for its Phesgo to treat early and metastatic HER2-positive breast cancer.
Phesgo is a fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase, which is administered by subcutaneous injection in combination with intravenous (IV) chemotherapy.
Phesgo is said to be Roche’s first product that combines two monoclonal antibodies, which can be administered by a single SC injection.
The approval of Phesgo was based on data from the pivotal phase III FeDeriCa study, which achieved its primary endpoint with Phesgo demonstrating non-inferior levels of Perjeta in the blood during a given dosing interval (Ctrough) when compared to IV administration of Perjeta.
FeDeriCa is an international, multi-centre, two-arm, randomised and open-label trial designed to assess the pharmacokinetics, efficacy and safety of subcutaneous injection of Phesgo in combination with chemotherapy compared with standard intravenous (IV) infusions of Perjeta and Herceptin in combination with chemotherapy in 500 people with HER2-positive early breast cancer treated in the neoadjuvant (before surgery) and adjuvant (after surgery) settings.
The trial’s secondary endpoints comprise of participant-reported satisfaction and health-related quality of life outcome, healthcare professionals’ perceptions of time and resource use and convenience compared with IV formulations, as well as the safety and efficacy of each study regimen.
Roche chief medical officer and global product development head Dr 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.”
In March this year, Roche announced that it will begin a phase III clinical trial of Actemra/RoActemra (tocilizumab) in hospitalised patients with severe Covid-19 pneumonia.