CHMP recommends EU approval of Roche’s Phesgo (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection) for HER2-positive breast cancer

  • Phesgo offers faster and less invasive delivery of standard of care treatment with Perjeta and Herceptin, under the skin in just minutes, compared to hours with intravenous infusion1,2,3
  • Subcutaneous administration is preferred by patients, physicians and healthcare providers, and can be associated with reduced hospital times and costs4,5,6
  • This is the first time that Roche has combined two monoclonal antibodies that can be administered by a single subcutaneous injection

Basel, 13 November 2020 - Roche today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Phesgo , a fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase, administered by subcutaneous (SC; under the skin) injection in combination with intravenous (IV) chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer. Based on this recommendation, a final decision regarding the approval of Phesgo is expected from the European Commission in the near future.

"Our commitment to transforming the lives of people with breast cancer goes beyond improving efficacy outcomes," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "Today’s recommendation is another important step forward in redefining the standard of care for people with HER2-positive breast cancer in Europe by potentially offering a faster and less invasive way to receive treatment with Perjeta and Herceptin."

SC administration of Phesgo takes approximately eight minutes for the initial loading dose and approximately five minutes for each subsequent maintenance dose.1 This is compared to approximately 150 minutes for 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.2,3

The recommendation from the CHMP is based on results from the pivotal phase III FeDeriCa study, which showed that treatment with Phesgo produced non-inferior levels of Perjeta and Herceptin in the blood when compared to IV administration of the two medicines. 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, including no meaningful difference in cardiac toxicity. The most common adverse events in both arms were alopecia, nausea, diarrhoea and anaemia.1,7

The U.S. Food and Drug Administration recently expedited the approval of Phesgo for the treatment of early and metastatic HER2-positive breast cancer. Based on the decision of the treating physician and the preference of the patient, it can be administered by a healthcare professional in a treatment centre or in a patient’s home.

The Herceptin SC vial is approved for the treatment of HER2-positive breast cancer in more than 100 countries worldwide and provides a convenient treatment option for patients and cost-savings for healthcare systems.5,6 Phesgo is another step forward in highlighting Roche’s commitment to improving patients’ experience of cancer treatment, looking beyond efficacy outcomes and focusing on more flexible treatment solutions.

About the FeDeriCa study
FeDeriCa is an international, multi-centre, two-arm, randomised, open-label, pivotal phase III study evaluating 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 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 include safety; minimum levels of Herceptin in the blood during a given dosing interval (Ctrough); and total pathological complete response, meaning there is no tumour tissue detectable in the tissue removed at the time of surgery.

Data from the FeDeriCa study were presented at the San Antonio Breast Cancer Symposium in December 2019. The FeDeriCa study met its primary endpoint of non-inferior levels of Perjeta in the blood. The geometric mean ratio (GMR; a type of average used when assessing pharmacokinetics) for the primary endpoint was 1.22 (90% CI: 1.14 to 1.31), with the lower limit of the 90% CI of the GMR=1.14