SHERIDAN, WYOMING – May 8, 2025 – Roche has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending an update to the European Union (EU) label for Phesgo®, a subcutaneous (SC) fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab), used for treating HER2-positive breast cancer. The label update will allow for Phesgo to be administered outside of clinical settings, such as at patients’ homes, under the supervision of a healthcare professional.
This strategic recommendation marks a significant advancement in the delivery of cancer treatments, aligning with patient preferences and improving overall healthcare system efficiency. The move towards at-home administration is expected to reduce the strain on healthcare facilities and is expected to bring substantial cost savings for both patients and healthcare systems.
Phesgo's Expansion: A Breakthrough for Cancer Care
Phesgo’s potential to be administered outside of clinical settings offers notable benefits, especially for patients undergoing treatment for HER2-positive breast cancer. Currently, treatment for this aggressive form of breast cancer typically requires intravenous (IV) administration in clinical environments. Phesgo, however, is a subcutaneous option, which provides faster treatment with a simpler and more manageable administration process.
Key benefits of Phesgo’s at-home administration include:
- Patient Convenience: Phesgo’s administration at home minimizes hospital visits, reducing patient anxiety and saving time, which enhances their quality of life.
- Healthcare Capacity Relief: By allowing healthcare professionals to administer Phesgo outside clinical settings, valuable healthcare resources can be reallocated, reducing the burden on hospitals and clinics.
- Cost Efficiency: In Western Europe, switching from IV Perjeta and Herceptin to Phesgo has shown to reduce treatment administration costs by up to 80%, offering substantial savings to both patients and healthcare systems.
A Shift Towards At-Home Treatment for HER2-Positive Breast Cancer
The positive opinion from the CHMP is based on a robust body of clinical, real-world, and bioequivalence data. These results, alongside data from the United States expanded access study, AL42478, support the feasibility and safety of at-home Phesgo administration. The study demonstrated that not only is at-home administration safe when conducted by a healthcare professional, but it is also preferred by patients, with no new safety concerns raised.
Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development, stated, “Between 2017 and 2023, the socioeconomic burden of HER2-positive breast cancer in ten major economies was nearly $590 billion, projected to increase to nearly $1,000 billion by 2032. At-home treatment may help alleviate the pressure on healthcare systems through significant capacity savings. This aligns with patient preferences, as data indicate 91% favor at-home administration over in-clinic treatment.”
Impact on HER2-Positive Breast Cancer Treatment
Phesgo has already been approved in over 120 countries and regions as a subcutaneous alternative to the intravenous versions of Perjeta and Herceptin. In addition to its faster administration time of approximately eight minutes, compared to the hours required for traditional IV treatments, Phesgo offers a promising option for both early-stage and metastatic HER2-positive breast cancer patients.
- 85% of patients prefer subcutaneous (SC) over intravenous (IV) administration, according to studies.
- The transition to Phesgo’s SC formulation can provide up to 80% in treatment administration cost savings in Western Europe.
These advancements underscore Roche’s commitment to improving patient outcomes through innovative therapies that are not only clinically effective but also socially and economically beneficial.
Conclusion: A New Era in Cancer Care
The update to Phesgo’s label represents a step forward in transforming cancer care. By offering a treatment that can be administered outside of clinical settings, Roche is enabling a more patient-centric approach, while also delivering operational efficiencies that help reduce healthcare costs. As the healthcare landscape evolves, Roche remains at the forefront, continuing to deliver groundbreaking solutions for people with HER2-positive breast cancer.
Learn more at www.roche.com.