publication date: Jul. 2, 2020
Drugs & Targets
Phesgo receives FDA approval in breast cancer indication for at home treatment
Phesgo, a combination of pertuzumab, trastuzumab and hyaluronidase–zzxf—has received FDA approval for injection under the skin to treat adult patients with HER2-positive breast cancer that has spread to other parts of the body, and for treatment of adult patients with early HER2-positive breast cancer.
Phesgo is sponsored by Genentech.
Patients should be selected based on an FDA-approved companion diagnostic test.
Efficacy was investigated in FeDeriCa (NCT03493854), an open-label, multicenter, randomized trial enrolling 500 patients with operable or locally advanced HER2-positive breast cancer. Patients were randomized to receive neoadjuvant chemotherapy with concurrent administration of either PHESGO or intravenous pertuzumab and intravenous trastuzumab during the neoadjuvant and adjuvant therapies.
The primary endpoint of FeDeriCa was non-inferiority of cycle seven pertuzumab serum trough concentration comparing PHESGO to intravenous pertuzumab. Secondary endpoints included cycle 7 trastuzumab serum trough concentration, pathological complete response, and safety. PHESGO showed non-inferior pertuzumab and trastuzumab serum trough concentrations compared to intravenous pertuzumab and trastuzumab.
The pCR rate was 59.7% (95% CI: 53.3, 65.8) in the Phesgo arm and 59.5% (95% CI: 53.2, 65.6) in the intravenous pertuzumab and intravenous trastuzumab arm. The safety profile of PHESGO is comparable to intravenous pertuzumab and trastuzumab, except for increased administration-related reactions.
Pertuzumab and trastuzumab bind to sites on HER2 and disrupt signaling to stop cancer cell growth. Phesgo is initially used in combination with chemotherapy and could continue to be administered at home by a qualified health care professional once the chemotherapy regimen is finished.
“Currently, most patients with HER2-positive breast cancer receive trastuzumab and pertuzumab at infusion centers. With a new … Continue reading Phesgo receives FDA approval in breast cancer indication for at home treatment
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