Roche seeks regulatory approval for Herceptin/Perjeta combo

Results of the FeDeriCa study has prompted Roche to apply for regulatory approval of its fixed-dose combination of the breast cancer drugs Herceptin (trastuzumab) and Perjeta (pertuzumab). In the phase 3 trial, the subcutaneous formulation of the two HER2-targeting drugs was just as effective at achieving therapeutic levels in the blood when given alongside chemotherapy as giving Herceptin and Perjeta by intravenous infusion.
The current Herceptin and Perjeta therapy requires a 150-minute infusion to provide a loading dose, followed by 60- to 150-minute maintenance doses. If approved, the new fixed-dose combination will provide an alternative to the use of Herceptin plus Perjeta, paving the way for a therapy for HER2-positive breast cancer that can be administered as a single injection in just eight minutes, with follow-up doses taking just five minutes.
Sandra Horning, Roche’s chief medical officer, said: “With this single injection under the skin, people with HER2-positive breast cancer receiving Perjeta and Herceptin can have a faster treatment option. Our medicines have helped millions of people living with HER2-positive breast cancer and this latest development is particularly exciting as, for the first time, we have combined two therapeutic antibodies as a single subcutaneous formulation.”