Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that it launched Phesgo® combination for Subcutaneous Injection MA, IN [generic name: pertuzumab (genetical recombination), trastuzumab (genetical recombination) and vorhyaluronidase alfa (genetical recombination) ] (hereafter, Phesgo), antineoplastic agent / anti-HER2 humanized monoclonal antibody for the treatment of “HER2-positive breast cancer” and “Advanced or recurrent HER2-positive colorectal cancer that has progressed following cancer chemotherapy and is not amenable to curative resection.” Phesgo had been approved by the Ministry of Health, Labour and Welfare (MHLW) on September 25, 2023 and was listed on the national health insurance (NHI) reimbursement price list today.
“We are very pleased to launch Phesgo in Japan, a fixed-dose combination for subcutaneous use containing the same anti-HER2 agents of Perjeta® and Herceptin®, the standard therapy for HER2-positive breast cancer. Phesgo is a drug that can be administered in a shorter time than conventional intravenous injections. As lifestyles and social environments diversify, shortening infusion time is expected to improve patients’ daily lives. In addition, since it is the fixed-dose subcutaneous injection that does not require preparation, it is expected to contribute to the efficiency of medical resources. With Phesgo as a new treatment option, we will work to promote its proper use so that we can deliver unprecedented value to patients undergoing cancer treatment in various settings, their families, and healthcare providers,” said Dr. Osamu Okuda, Chugai’s President and CEO.
Phesgo, this subcutaneous fixed-dose combination without preparation contains the same monoclonal antibodies as Perjeta and Herceptin, and also a vorhyaluronidase alfa (genetical recombination) combined in a single vial. It takes over eight minutes for a loading dose of Phesgo and over five minutes for the subsequent doses. By comparison, it takes 150 minutes for a sequential infusion of a loading dose of Perjeta and Herceptin using intravenous formulations (excluding follow-up observation), and 60-150* minutes for the subsequent maintenance dose infusions.1,2,3)
- *Both drugs can be shortened to 30 minutes if the initial administration is well tolerated
The regulatory approval is based on the results of the global phase III FeDeriCa study including Japan and an overseas phase II PHranceSCa study. FeDeriCa study evaluated the pharmacokinetics, efficacy, and safety of Phesgo with patients with HER2-positive breast cancer. PHranceSCa study examined patient preference and satisfaction with subcutaneous administration of Phesgo in HER2-positive breast cancer.