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| Image credit – US Public Health Emergency Weekly Report |
A combination of targeted therapy drugs pertuzumab, trastuzumab (Herceptin®) and hyaluronidase is commonly given to HER-2 positive breast cancer patients whose cancer has spread to other parts of the body as an intravenous infusion at a clinic.
Phesgo contains a fixed-dose combination of pertuzumab and trastuzumab with hyaluronidase for injection under the skin. The therapeutic components in Phesgo are the same as those in FDA-approved intravenous (IV) pertuzumab and IV trastuzumab.
The FDA’s approval was based on results of a clinical trial showing that the injection route of treatment was as effective as the infusion route. Having an in-home option for treatment of breast cancer is particularly important with the COVID-19 pandemic, ans was was part of the reason for the FDA’s approval at this time, according to Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence.
“As part of the FDA’s ongoing commitment to address the novel coronavirus pandemic, we continue to keep a strong focus on patients with cancer who constitute a vulnerable population at risk of contracting the disease," Pazdur said in a press release. "At this critical time, we continue to expedite oncology product development. This application was approved about four months ahead of the FDA goal date.”
The most common side effects for patients taking Phesgo were hair loss, nausea, diarrhea, anemia, and fatigue. Phesgo can also cause worsening of chemotherapy induced neutropenia or reduced immunity.
The latter side effect makes the ability to administer the treatment at home particularly important during this time of an infectious disease epidemic.
Source: FDA press release
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