According to the FDA, patients should be selected based on an FDA-approved companion diagnostic test.
Officials with the FDA have approved a fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase (Phesgo, Genentech) for injection under the skin to treat adult patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer that has spread to other parts of the body. Further, the combination is intended for the treatment of adult patients with early HER2-positive breast cancer.1
According to the FDA, patients should be selected based on an FDA-approved companion diagnostic test.1
Pertuzumab and trastuzumab have the ability to bind to sites on HER2 and disrupt signaling to stop cancer cell growth. With this, the fixed dose combination is used in addition to chemotherapy and could continue to be administered at home by a qualified health care professional once the chemotherapy regimen is finished, according to the FDA.1
The approval is based on the results of a noninferiority study in patients with HER2-positive early breast cancer, which demonstrated the combination of pertuzumab, trastuzumab, and hyaluronidase had comparable efficacy and safety as intravenous pertuzaumb and intravenous trastuzumab, except for administration-related reactions, which were higher with the combination due to the subcutaneous route of administration.1
“The fixed-dose combination of trastuzumab and pertuzumab offers a simpler, faster and easier treatment experience for patients with HER2-positive breast cancer,” said trial investigator Antoinette R. Tan, MD, MHSc, chief of breast medical oncology at Levine Cancer Institute, in an email to Pharmacy Times®. “This development is exciting because it makes the treatment process more efficient for patients, to be able to receive a drug subcutaneously instead of intravenously. A home administration protocol for this subcutaneous formulation is an area of current research and can be advantageous for patients and infusion centers, especially during the current pandemic.”2
The most common adverse effects for patients taking the fixed dose combination of pertuzumab, trastuzumab, and hyaluronidase were alopecia, nausea, diarrhea, anemia, and asthenia.1