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02-07-2020 | Oncology | News | Article

approvalsWatch

FDA approves outpatient combination HER2-positive breast cancer therapy

Author:
Lynda Williams

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.

medwireNews is an independent medical news service provided by Springer Healthcare. © 2020 Springer Healthcare part of the Springer Nature Group  

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