can home hylecta be far behind?
FDA Approves In-home Breast Cancer Treatment
Advantageous for Infusion Centers?
Nick Mulcahy
June 29, 2020
The US Food and Drug Administration approved a combination of pertuzumab (Perjeta, Genentech/Roche), trastuzumab (Herceptin, Genentech/Roche) and hyaluronidase (Phesgo, Genentech/Roche) that is administered subcutaneously — rather than intravenously — for the treatment of early and metastatic HER2-positive breast cancers.
Phesgo is initially used in combination with chemotherapy at an infusion center but could continue to be administered in a patient's home by a qualified healthcare professional once chemotherapy is complete, according to the FDA.
Administration takes approximately 8 minutes for the initial loading dose and approximately 5 minutes for maintenance doses, according to a Genentech press statement. This compares favorably to the 150 minutes needed for the combined loading dose of intravenous pertuzumab and trastuzumab, and the 60-150 minutes for IV maintenance infusions, the company said.
"Currently, most patients with HER2-positive breast cancer receive trastuzumab and pertuzumab at infusion centers. With a new administration route, Phesgo offers an outpatient option for patients to receive trastuzumab and pertuzumab," said Richard Pazdur, MD, director of the FDA's Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA's Center for Drug Evaluation and Research, in an agency press release.
"The fixed-dose combination of trastuzumab and pertuzumab offers a simpler, faster, and easier treatment experience for patients with HER2-positive breast cancer," said Antoinette Tan, MD, MHSc, chief of Breast Medical Oncology, Levine Cancer Institute, Charlotte, North Carolina, in the company statement.
Tan also said that home administration "can be advantageous for patients and infusion centers."
However, in April, the Community Oncology Alliance (COA) strenuously objected to this type of treatment in a patient's home, as reported by Medscape Medical News.
The group, which represents US community-based practices, said it "fundamentally opposes home infusion of chemotherapy, cancer immunotherapy, and cancer treatment supportive drugs because of serious patient safety concerns."
The FDA's approval was based on the results of the pivotal Phase III FeDeriCa trial, a non-inferiority study in patients with HER2-positive early breast cancer, which demonstrated that the new product had comparable efficacy and safety as IV pertuzumab and IV trastuzumab
In terms of efficacy, the subcutaneous product demonstrated non-inferior plasma levels of pertuzumab, which was the primary endpoint, when compared with IV administration of pertuzumab.
Safety was comparable between the two approaches, with no new safety signals using the subcutaneous delivery method, including no "meaningful difference" in cardiac toxicity, according to Genentech. However, there were more administration-related reactions with the new product. The most common adverse events in both groups were alopecia, nausea, diarrhea and anemia.
The new product uses a drug delivery technology (Enhanze, Halozyme Therapeutics) that employs a proprietary enzyme that temporarily degrades hyaluronan, a glycosaminoglycan or chain of natural sugars in the body, to facilitate the dispersion and absorption of injected therapeutic drugs, according to Genentech.
In May, at the European Society for Medical Oncology Breast Cancer Virtual Meeting 2020, investigators of the phase 2 PHranceSCa study reported that "more than 80%" of patients preferred subcutaneous to IV administration of pertuzumab and trastuzumab.
Nick Mulcahy is an award-winning senior journalist for Medscape. He previously freelanced for HealthDay and MedPageToday and had bylines in WashingtonPost.com, MSNBC, and Yahoo. Email:
nmulcahy@medscape.net and on Twitter: @MulcahyNick