New Herceptin-Perjeta Formulation Shows Promising Safety and Pharmacokinetic Profile, Phase 3 Trial Shows

New Herceptin-Perjeta Formulation Shows Promising Safety and Pharmacokinetic Profile, Phase 3 Trial Shows
When given together with Herceptin (trastuzumab) at a fixed dose through an under-the-skin (subcutaneous) injection, Perjeta (pertuzumab) reaches levels in the blood in women with HER2-positive breast cancer that is similar to those seen when the medication is administered intravenously, data from a Phase 3 trial shows. This new mode of administration also is faster than the standard intravenous route, the trial found. These are the first findings of the global, randomized, open-label, FeDeriCa Phase 3 trial (NCT03493854). The study is being conducted by Genentech, a subsidiary of Roche, at 122 sites worldwide. FeDeriCa was the first study to investigate the pharmacokinetic properties and safety profile of a subcutaneous fixed-dose combination of Perjeta-Herceptin when administered together with intravenous chemotherapy, in a group of women with HER2-positive breast cancer. Pharmacokinetics is the study of how a drug is absorbed, distributed, metabolized, and eliminated from the body — basically, what the body does to a drug. The simultaneous administration of both medications through an under-the-skin injection was performed using Halozyme Therapeutics
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