Roche has secured approval from the European Commission (EC) 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 designed to be used as subcutaneous (SC) injection.
Phesgo integrates the same monoclonal antibodies as Perjeta and Herceptin with Halozyme Therapeutics’ Enhanze drug delivery technology in a novel formulation for SC use.
Phesgo, which is available as a single-dose vial for SC injection, enables more than 90% faster treatment than IV administration of standard of care therapy with Perjeta and Herceptin.
The regulator approved Phesgo based on data from the pivotal phase III FeDeriCa study, which demonstrated that treatment with Phesgo generated non-inferior levels of Perjeta and Herceptin in the blood and shown comparable efficacy versus intravenous (IV) administration of the two medicines, said the company.
FeDeriCa is an international, multi-centre, two-arm, randomised, open-label and phase III study designed to assess the pharmacokinetics, efficacy and safety of subcutaneous injection of Phesgo in combination with chemotherapy.
The trial compared Phesgo with 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.
According to the company, the primary endpoint of the study is minimum levels of Perjeta in the blood during a given dosing interval (Ctrough), when compared to IV administration of Perjeta.
Secondary endpoints consist of safety, minimum levels of Herceptin in the blood during a given dosing interval (Ctrough) and total pathological complete response.
Roche global product development head and chief medical officer Dr Levi Garraway said: “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.”