FDA approves Phesgo, at-home treatment regimen for breast cancer
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The FDA today approved Phesgo, the combination of pertuzumab, trastuzumab and hyaluronidase-zzxf, for the treatment of adults with HER2-positive breast cancer.
Phesgo (Genentech) — indicated for adults with early-stage or metastatic disease — contains the same therapeutic components as IV trastuzumab (Herceptin, Genentech) and pertuzumab (Perjeta, Genentech).
It is initially used in combination with chemotherapy and then can be administered subcutaneously at home by a health care professional after completion of chemotherapy, according to a press release from the FDA.
“Currently, most patients with HER2-positive breast cancer receive trastuzumab and pertuzumab at infusion centers,” 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, said in the press release. “With a new administration route, [this combination] offers an outpatient option for patients to receive trastuzumab and pertuzumab.”
The FDA based the approval of Phesgo on data from a noninferiority trial in which researchers randomly assigned 500 patients with operable or locally advanced HER2-positive breast cancer to neoadjuvant chemotherapy with concurrent administration of Phesgo or IV pertuzumab and trastuzumab in the neoadjuvant and adjuvant settings.
Noninferiority of cycle 7 pertuzumab serum trough concentration with Phesgo vs. IV pertuzumab served as the primary endpoint. Cycle 7 trastuzumab serum trough concentration, pathologic complete response and safety served as secondary endpoints.
Results showed Phesgo conferred noninferior pertuzumab and trastuzumab serum trough concentrations compared with the IV formulation.
Additionally, results showed comparable pathologic complete response rates of 59.7% (95% CI, 53.5-65.8) in the Phesgo group and 59.5% (95% CI, 53.2-65.6) in the IV group.
Safety profiles were similar between the groups. The most common adverse events associated with Phesgo included alopecia, nausea, diarrhea, anemia and asthenia. Phesgo also can worsen chemotherapy-induced neutropenia.
“As part of the FDA’s ongoing commitment to address the novel coronavirus pandemic, we continue to keep a strong focus on patients with cancer who constitute a vulnerable population at risk [for] contracting the disease,” Pazdur said. “At this critical time, we continue to expedite oncology product development. This application was approved about 4 months ahead of the FDA goal date.”
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