MHLW (Japan) approval for Phesgo, the fixed-dose subcutaneous combination of Perjeta and Herceptin for HER2-positive breast and colorectal cancer – Chugai

Chugai Pharmaceutical Co., Ltd. announced that it has obtained regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for 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.”

“We are pleased to have obtained approval in Japan for Phesgo, 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. Reducing administration time is expected to improve convenience for patients and reduce the burden on healthcare system and professionals. We are preparing for the launch of this drug so that it can be used for treatment as soon as possible,” said Dr. Osamu Okuda, Chugai’s President and CEO.

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.