EMA Committee recommends EU label update for Roche Phesgo to allow administration outside of clinical settings
Basel: 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), for human epidermal growth factor receptor 2 (HER2)-positive breast cancer. Administration of Phesgo outside of a clinical setting (such as in a person’s home) by a healthcare professional will be possible, once safely established in a clinical setting.
Each year, almost half a million people are diagnosed with HER2-positive breast cancer worldwide and treatment can impact a person’s ability to work and contribute to society.
"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," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “At-home treatment may help alleviate the pressure on healthcare systems through significant capacity savings. This aligns with patient preferences, as data indicate 91% favour at-home administration over in-clinic treatment.”
"Treatments, like Phesgo, that can be administered at home offer patients a more manageable option, with the potential to improve their quality of life," said Sandrine Lavallé from European Patients Academy on Therapeutic Innovation (EUPATI), Luxembourg. "This reduces the burden of hospital commuting time, anxiety associated with being in a hospital infusion chair, and minimises disruption to daily life. Patient safety is paramount, requiring clear instructions, education, and support for at-home treatment."
The CHMP positive opinion is supported by results from clinical, real-world and bioequivalence data, drug safety reports and the United States expanded access study, AL42478, in people with early-stage and metastatic HER2-positive breast cancer, which demonstrated that at-home administration of Phesgo by a healthcare professional was feasible, preferred by patients, and with no new safety signals observed.
Phesgo is already approved as a SC alternative to intravenous (IV) Perjeta and Herceptin for people with HER2-positive early-stage and metastatic breast cancer in more than 120 countries/regions. In Western Europe, switching from IV Perjeta and Herceptin to Phesgo has been shown to reduce treatment administration costs by up to 80% and studies indicate that 85% of individuals with breast cancer prefer SC over IV administration.
