Subcutaneous Combination Therapy Approved by FDA for HER2-Positive Breast Cancer
Posted: Tuesday, June 30, 2020
On June 29, the U.S. Food and Drug Administration (FDA) approved the subcutaneous use of Phesgo, a fixed-dose combination treatment consisting of pertuzumab, trastuzumab, and hyaluronidase-zzxf—for adults with metastatic HER2-positive breast cancer or early HER2-positive breast cancer. Treatment eligibility will be determined by an FDA-approved companion diagnostic test. The injection can be administered at home by a health-care professional.
The FDA approval was based on data from a noninferiority study evaluating patients with HER2-positive early breast cancer. Patients administered the combination therapy showed comparable efficacy and safety outcomes when compared with patients administered intravenous doses of pertuzumab and trastuzumab. However, higher incidences of administration-related reactions were reported in patients given the combination therapy subcutaneously than in patients given pertuzumab and trastuzumab intravenously.
The most common side effects for patients taking the combination therapy via subcutaneous injection included alopecia, nausea, diarrhea, anemia, and asthenia. In addition, it may also worsen chemotherapy-induced neutropenia.