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news.Roche has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for updating the European Union (EU) label of Phesgo.
The company’s studies suggest that 85% of breast cancer individuals favour SC over intravenous administration. Credit: marijana1 on Pixabay.
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This fixed-dose combo of Perjeta (pertuzumab) and Herceptin (trastuzumab), delivered via SC injection along with intravenous chemotherapy, offers a subcutaneous (SC) treatment option for human epidermal growth factor receptor 2 (HER2)-positive breast cancer.
The committee’s recommendation allows the possibility of administration out of clinical settings, for example, at home, with the help of healthcare professionals, after safe establishment in a clinical setting.
It is based on the outcomes from clinical, bioequivalence data, real-world evidence, drug safety reports, and the US expanded access trial AL42478.
These sources have shown that at-home administration of the therapy is feasible, favoured by individuals, and does not present new safety concerns.
The therapy has already gained approval as an SC alternative to intravenous Perjeta and Herceptin in over 120 nations for HER2-positive early-stage and metastatic breast cancer.
According to Roche, in Western Europe, transitioning to Phesgo from intravenous Perjeta and Herceptin has demonstrated up to an 80% reduction in treatment administration expenses.
Furthermore, studies suggest that 85% of breast cancer individuals favour SC over intravenous administration.
For over three decades, Roche claims to have been researching the HER2 pathway for enhancing the lives of individuals living with early-stage and metastatic HER2-positive conditions.
The administration of the company’s HER2-targeted therapies is contingent upon a diagnostic test that ascertains the suitability of patients for these treatments early in their disease progression.
Roche Global Product Development head and chief medical officer Levi Garraway said: “Between 2017 and 2023, the socioeconomic burden of HER2-positive breast cancer in ten major economies was nearly $590bn, projected to increase to nearly $1,000bn 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% favour at-home administration over in-clinic treatment.”
