Roche announced Monday that the FDA has approved Phesgo, a fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) with Halozyme Therapeutics' Enhanze drug-delivery technology, administered via subcutaneous injection, to treat patients with early and metastatic HER2-positive breast cancer. The company said Phesgo, which can be given by a health professional in a treatment centre or at a patient's home, "offers faster administration of Perjeta and Herceptin under the skin in just minutes, compared to hours with standard intravenous (IV) administration."
Levi Garraway, head of global product development at Roche, remarked that "Phesgo offers a treatment administration that supports the needs and preferences of individual patients, and helps to meet the increasing demand across the healthcare system for faster and more flexible treatment options."
FDA approval follows a review of data from the pivotal Phase III FeDeriCa study, evaluating subcutaneous injection of Phesgo in combination with chemotherapy, compared with standard IV infusions of Perjeta and Herceptin plus chemotherapy, in 500 patients with HER2-positive early breast cancer treated in the neoadjuvant and adjuvant settings. The study, which was presented at last year's San Antonio Breast Cancer Symposium (SABCS), met its primary endpoint with Phesgo showing non-inferior levels of Perjeta in the blood during a given dosing interval, when compared to IV administration of Perjeta. Phesgo and chemotherapy were also comparable to IV administration of Perjeta plus Herceptin and chemotherapy in terms of safety, with no new signals identified, including no meaningful difference in cardiac toxicity.
Cuts treatment administration down to minutes
According to Roche, administration of Phesgo, which comes in a single-dose vial, can take about eight minutes for the initial loading dose and then five minutes for each subsequent maintenance dose. By comparison, its take roughly 150 minutes for a sequential infusion of a loading dose of Perjeta and Herceptin using standard IV formulations, and between 60 minutes to 150 minutes for subsequent maintenance infusions of the two medicines, the company noted.
Roche cited data from the Phase II PHranceSCa study indicating that 85% of 160 patients receiving treatment for HER2-positive breast cancer preferred treatment under the skin to IV administration, due to less time in the clinic and more comfortable treatment administration.
Last year, the FDA cleared Herceptin Hylecta (trastuzumab/hyaluronidase-oysk), which also uses Enhanze technology, as a subcutaneous injectable treatment for certain patients with HER2-positive early breast cancer in combination with chemotherapy. The subcutaneous formulation of Herceptin is cleared in over 100 countries, including in Europe, after Roche signed a deal in 2006 to use the Enhanze technology in its biological therapeutic compounds.
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