Is Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) on the market?

On June 29, 2020, the U.S. Food and Drug Administration (FDA) approved subcutaneous injection of Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) for the treatment of patients with HER2-positive early and metastatic breast cancer. Patients should be selected for treatment based on FDA-approved companion diagnostic tests. Approval was based primarily on the FeDeriCa trial, a randomized, open-label, multicenter comparability study that compared subcutaneous Phesgo with intravenous trastuzumab in neoadjuvant and adjuvant chemotherapy in patients with early-stage breast cancer.

The recommended initial dose of Phesgo is 1200 mg pertuzumab, 600 mg trastuzumab and 30,000 units of hyaluronidase administered subcutaneously over approximately 8 minutes, followed every 3 weeks by 600 mg of pertuzumab, 600 mg of trastuzumab and 20,000 units of hyaluronidase administered subcutaneously over approximately 5 minutes. The pharmacokinetic endpoints were first to demonstrate that subcutaneous pertuzumab was noninferior to intravenous pertuzumab and then to demonstrate that subcutaneous trastuzumab was noninferior to intravenous trastuzumab. The primary endpoint met the lower limit of the observed two-sided 90% confidence interval and was above the prespecified noninferiority margin. The most common adverse reactions are hair loss, nausea, diarrhea, anemia and fatigue. All evidence demonstrates comparability of subcutaneous to intravenous products, allowing for inference and approval of intravenous Pertuzumab/trastuzumab for all breast cancer indications for which it is approved.

The original Phesgo drug is not marketed in the country and therefore cannot be included in medical insurance. Since Phesgo's original drug has been on the market overseas for a short time, there is less price and other related information. For specific prices and drug information, please consult Yaode's medical consultant.