EMA Committee recommends EU label update for Roche Phesgo to allow administration outside of clinical settings

"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.