FDA approves outpatient combination HER2-positive breast cancer therapy
medwireNews: US patients with HER2-positive breast cancer may now receive pertuzumab, trastuzumab, and hyaluronidase as a single subcutaneous injection, raising the possibility of home use.
Pertuzumab, trastuzumab, and hyaluronidase-zzxf may be given as a neoadjuvant treatment for locally advanced, inflammatory or early-stage breast cancer, or as an adjuvant therapy for patients with early disease and a high risk of recurrence.
The agent may also be given alongside docetaxel to patients with metastatic disease who have not previously received chemotherapy or HER2-targeted treatment, the FDA’s prescribing information states.
The approval is based on findings from the FeDeriCa trial of patients with operable or locally advanced HER2-positive breast cancer, demonstrating noninferiority of pertuzumab and trastuzumab serum trough concentrations with the subcutaneous agent compared with intravenous pertuzumab and trastuzumab.
“Currently, most patients with HER2-positive breast cancer receive trastuzumab and pertuzumab at infusion centers”, explains Richard Pazdur, director of the FDA Oncology Center of Excellence in a press release.
“With a new administration route, [pertuzumab, trastuzumab, and hyaluronidase-zzxf] offers an out-patient option for patients to receive trastuzumab and pertuzumab.”
Pertuzumab, trastuzumab, and hyaluronidase-zzxf is recommended to be initially administered over approximately 8 minutes at a dose of pertuzumab 1200 mg, trastuzumab 600 mg and hyaluronidase 30,000 U, followed by 3-weekly doses of pertuzumab 600 mg, trastuzumab 600 mg and hyaluronidase 20,000 U given over around 5 minutes.
The agent has a boxed warning for heart failure, fetal harm, and lung toxicity, and the recommendation that patients should undergo monitoring as per use of intravenous pertuzumab and trastuzumab.
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