The new drug against breast cancer that reduces a treatment to 5 minutes

He The Ministry of Health has given the green light to the financing of Phesgoa fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase, administered by subcutaneous (SC) injection for the treatment of early and metastatic HER2 positive breast cancer.

He HER2 positive breast cancer is a particularly aggressive form of the disease that affects approximately 20% of patients. Until nowthis treatment was administered intravenously and required hours, compared to the minutes represented by the SC route, maintaining the same efficiency. The SC route is preferred by patients and healthcare professionals, and can be associated with a reduction in healthcare costs. It is the first formulation in oncology that combines the two monoclonal antibodies, pertuzumab and trastuzumab, in the same vial for SC injection.

This treatment is available as a single-dose vial for SC injection and allows for a faster administration than standard intravenous pertuzumab and trastuzumab. Its administration via SC requires approximately eight minutes for initial loading dose and, approximately, five minutes for each maintenance dose later. This compares to approximately 150 minutes which requires infusion of a loading dose of Perjeta and Herceptin, using the standard intravenous formulations, and 60 to 90 minutes of subsequent maintenance infusions of both drugs.

As pointed out by Dr. Beatriz Perez Sanzmedical director of Roche Farma Spain, “this approval represents an important step forward in the treatment of this type of breast cancer. The innovation it brings allows us to significantly reduce the time people spend receiving standard therapy with pertuzumab and trastuzumab, potentially helping to minimize the impact that the treatment has on their daily lives.”

Dr. Jose Angel Garcia Saenza medical oncologist at the Hospital Clínico San Carlos in Madrid, who highlights that, “thanks to this new formulation, patients spend much less time in the day hospital. They do not need to be there mornings or even entire days to receive their medication, something very important considering that they must go to the hospital every three weeks to receive their medication. Added to this is that this administration is less invasive and is usually associated with fewer risks compared to the intravenous route. To explain it in a very simple way, It is a way to reverse a disease situation, making these women feel less sick”.

For her part, Dr. Eva Ciruelosa medical oncologist at the Breast Cancer Unit of the Hospital 12 de Octubre in Madrid, emphasizes that “we must bear in mind that cancer is going to be something very common in our society and specifically breast cancer, which is a tumor with more than 35,000 new cases a year in our country. Therefore, these long treatments must be compatible with the daily life of the patients, so that they can go to work, take care of their children or do their daily tasks. And for that, without a doubt, we need therapies that are not only effective, preventing the disease from progressing, but also that they are comfortable and help to reconcile the personal life of patients and, of course, without increasing side effects”.

It all started 25 years ago

Approximately 25 years ago studies with trastuzumab showed its efficacy to treat patients with early breast cancer, and to increase survival in those with advanced disease. “Later,” explains Dr. García Sáenz, “it was found that incorporating two antibodiesthat is, add pertuzumab to trastuzumab, increased the cure rate in early stages and survival and quality of life in those with very advanced metastatic disease. This was a milestone in the management of HER2-positive breast cancer. From there, we have not stopped researching and advancing to cure more patients or, at least, prolong the quality of life in those cases in which the disease is not curable”.

The new and promising drug that doubles survival in breast cancer

EFE

In this context, Dr. Ciruelos adds that “there are two drugs, pertuzumab and trastuzumab, that we were already using And, precisely, what innovation allows is to give a twist to something that already works, adding additional advantages. And this is what has been achieved in this case, beyond its efficacy against the tumor, which is what we already had with the intravenous version”.

FeDerica Studio

The approval was based on the results of the phase III FeDeriCa study, which showed that treatment with Phesgo produced non-inferior levels of pertuzumab and trastuzumab in the blood, compared to intravenous administration of the two drugs. Your security profile, in combination with chemotherapy, was comparable to IV administration of pertuzumab and trastuzumab in combination with chemotherapy. No new safety signals were identifiedincluding no significant difference in cardiac toxicity.

11 Spanish hospitals have participated in clinical studies that support the approval of this new route of administration. “Spanish oncology always is at the forefront of clinical research and, thanks to the participation we have had in the trials with this route of administration, we have experience with this subcutaneous treatment, despite the fact that its financing has arrived so late in Spain”, adds Dr. Ciruelos.

He The Ministry of Health has given the green light to the financing of Phesgoa fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase, administered by subcutaneous (SC) injection for the treatment of early and metastatic HER2 positive breast cancer.