Roche to file subcutaneous breast cancer combo

The subcutaneous formulation of Roche’s combination therapy in HER2-positive early breast cancer is non-inferior to the original intravenous version, a study shows.

Roche announced the phase III FeDeriCa study met its primary endpoint. The study showed a new investigational fixed-dose combination (FDC) of Perjeta (pertuzumab) and Herceptin (trastuzumab), administered by subcutaneous (SC) injection in combination with intravenous (IV) chemotherapy, demonstrated non-inferior levels of Perjeta in the blood (pharmacokinetics) compared to standard IV infusion of Perjeta plus Herceptin and chemotherapy in people with HER2-positive early breast cancer (eBC). The safety profile of the FDC of Perjeta and Herceptin was consistent with that of Perjeta and Herceptin administered intravenously.¹

“With this single injection under the skin, people with HER2-positive breast cancer receiving Perjeta and Herceptin can have a faster treatment option,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “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.”

SC administration of the FDC takes approximately 8 minutes for the initial loading dose, and approximately 5 minutes for each subsequent maintenance dose. This is compared to approximately 150 minutes for infusion of a loading dose of Perjeta and Herceptin using the standard IV formulations, and between 60-150 minutes for subsequent maintenance infusions for the combination.¹

Roche said data will be submitted to health authorities around the world, including the US Food and Drug Administration and European Medicines Agency.

It’s an opportunity to protect sales as after many years Roche’s big three cancer drugs – Herceptin, Rituxan, and Avastin – are under threat from cheaper biosimilars.

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