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FDA Approves Fixed-Dose Combo Injection for Certain Adults With HER2+ Breast Cancer
On June 29, 2020, the FDA approved a subcutaneous injection comprising a fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase–zzxf (Phesgo; Genentech) for the treatment of adults with metastatic HER2-positive breast cancer and early HER2-positive breast cancer.
An FDA-approved companion diagnostic test should be used to determine patient eligibility for this combination regimen. Initially administered in combination with chemotherapy, the fixed-dose injectable can be administered at home by a qualified healthcare professional once chemotherapy is complete.
“Currently, most patients with HER2-positive breast cancer receive trastuzumab and pertuzumab at infusion centers. With a new administration route, Phesgo offers an out-patient option for patients to receive trastuzumab and pertuzumab,” said Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence, in a press statement.
This approval was based on findings from a noninferiority study of patients with HER2-positive, early breast cancer, in which the combination injectable had safety and efficacy comparable with that of intravenous (IV) pertuzumab and IV trastuzumab. Administration-related reactions, however, were noted to be higher with the fixed-dose injectable because of the subcutaneous route of administration.
Side effects most frequently associated with the injection were alopecia, nausea, diarrhea, anemia, and asthenia.—Hina M. Porcelli
Source: US Food and Drug Administration. FDA approves breast cancer treatment that can be administered at home by health care professional. June 29, 2020. www.fda.gov/news-events/press-announcements/fda-approves-breast-cancer-treatment-can-be-administered-home-health-care-professional. Accessed June 29, 2020.
