A new drug for breast cancer patients can be administered at home.
- The positive recommendation was based on data from clinical trials, medical practice and bioequivalence analyses confirming the possibility and safety of administering the drug outside clinical settings, e.g. at home.
- The potential extension of the summary of product characteristics for the drug responds to patients' preferences for treatment at home and is an important step towards relieving the burden on the oncology care system in clinical settings.
- The drug has the potential to reduce the cost of therapy by up to 80% in Western Europe, with 85% of patients preferring subcutaneous administration over intravenous administration.
Roche announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the updated summary of product characteristics for Phesgo in the European Union. Phesgo is a subcutaneous, fixed-dose combination of pertuzumab and trastuzumab for use in patients with HER2-positive breast cancer .
The update will enable the drug to be administered by healthcare professionals outside clinical settings – for example, at home – after the therapy has been safely implemented in a hospital setting.
Nearly half a million people worldwide are diagnosed with HER2-positive breast cancer each year, and treatment can impact a person's ability to work and participate in social activities.
"The socioeconomic burden of HER2-positive breast cancer in the world's ten largest economies was nearly $590 billion between 2017 and 2023, and could reach close to $1 trillion by 2032," said Dr. Levi Garraway, Roche's Chief Medical Officer and Head of Global Product Development. "Home therapy can reduce the burden on healthcare systems by saving resources while also meeting patient needs – 91% of patients prefer treatment at home over hospital," he emphasized.
"Treatment with a drug that can be administered at home is a more convenient option for patients and an opportunity to improve the quality of therapy and quality of life. It reduces the need for travel to the hospital, reduces the stress associated with administration in an infusion chair, and limits disruption to daily life. However, patient safety must remain a priority, which requires clear instructions, education, and support," added Sandrine Lavallé from the European Patients' Academy for Therapeutic Innovation (EUPATI) in Luxembourg.
The CHMP's positive opinion was based on data from clinical trials, clinical practice, bioequivalence data, and safety reports, as well as the results of the US expanded access program AL42478. Studies have shown that home administration by qualified healthcare professionals is feasible, safe, and preferred by patients.
The drug is already approved as a subcutaneous alternative to intravenous formulations containing pertuzumab and trastuzumab for the treatment of HER2-positive breast cancer in more than 120 countries. In Western Europe, switching from the intravenous to the subcutaneous version can reduce treatment costs by up to 80%, and 85% of patients prefer this form of treatment.
It is a fixed-dose combination drug containing pertuzumab and trastuzumab with the addition of hyaluronidase, intended for subcutaneous (SC) injection in the treatment of early and metastatic HER2-positive breast cancer.
Standard intravenous formulations of pertuzumab and trastuzumab in combination with chemotherapy (so-called pertuzumab-based regimens) are approved in more than 120 countries/regions for the treatment of both early and metastatic HER2-positive breast cancer.
In the neoadjuvant (preoperative) treatment of HER2-positive breast cancer, a pertuzumab-based regimen can almost double the pathological complete response rate compared with trastuzumab plus chemotherapy.
Additionally, this combination has been shown to significantly reduce the risk of invasive disease recurrence or death in the adjuvant (post-operative) setting for early breast cancer.
In the setting of metastatic disease, this combination provides a significant survival benefit in previously untreated (first-line) patients with HER2-positive metastatic breast cancer.
The drug pertuzumab + trastuzumab in one subcutaneous injection lasting approximately 5-8 minutes enables a more convenient and much faster administration of preparations containing pertuzumab and trastuzumab, traditionally administered via intravenous infusions lasting many hours.
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