The SC formulation of Perjeta and Herceptin with hyaluronidase was approved based on the results of the phase 3 FeDeriCa study
Roche secures approval from the EC for Phesgo SC injection for the treatment of HER2-positive breast cancer. (Credit: F. Hoffmann-La Roche Ltd)
Roche has secured approval from the European Commission (EC) for Phesgo subcutaneous (SC) injection for the treatment of early and metastatic HER2-positive breast cancer.
Phesgo is a fixed-dose combination of monoclonal antibodies Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase. The SC formulation has been developed using Halozyme Therapeutics Enhanze drug delivery technology.
Phesgo is available as a single-dose vial for SC injection.
In June 2018, the EC approved the combination of Perjeta and Herceptin (trastuzumab) and chemotherapy for post-surgery treatment of adults having HER2-positive early breast cancer (eBC) at high risk of recurrence.
According to Roche, treatment with Phesgo is over 90% faster, administered under the skin in just minutes when compared to hours of treatment with intravenous (IV) infusion of Perjeta and Herceptin combination.
The Swiss pharma company further stated that SC administration of Phesgo takes around eight minutes for the initial loading dose and nearly five minutes for each subsequent maintenance dose.
Roche chief medical officer and global product development head Levi Garraway said: “This approval represents a significant step forward in the treatment of HER2-positive breast cancer.
“The innovation of Phesgo significantly reduces the time people spend receiving standard of care therapy with Perjeta and Herceptin, helping to minimise the impact of treatment on their everyday lives. It also addresses the increasing demand across healthcare systems for faster and more flexible treatment solutions.”
Phesgo’s approval by EC has been driven by the findings of the phase 3 FeDeriCa study. In the late-stage clinical study, Phesgo delivered non-inferior levels of Perjeta and Herceptin in the blood and showed comparable efficacy in comparison to IV administration of the two drugs.
In June 2020, the Phesgo SC injection was approved by the US Food and Drug Administration (FDA) for the treatment of early and metastatic HER2-positive breast cancer.