New timesaving formulation of Roche’s Herceptin approved in EU

A new timesaving formulation of Roche's HER2-positive breast cancer drug, Herceptin, has been approved by the European Commission (EC). The new subcutaneous (injectable) formulation of Herceptin (trastuzumab) can be administered in two to five minutes, rather than 30 to 90 minutes with the standard intravenous form. The European approval is for both early and later stages of treatment.

"More than 90,000 women in Europe are diagnosed with HER2 positive breast cancer every year. We are pleased this new formulation of Herceptin may enable patients to spend less time in the hospital and more time getting on with their lives."

Hal Barron, MD, Roche's Chief Medical Officer and Head of Global Product Development.

The EC's approval was based on data from the HannaH clinical trial which showed that the subcutaneous formulation of Herceptin was associated with comparable efficacy (pathological complete response, pCR) to Herceptin administered intravenously in women with HER2-positive early breast cancer and resulted in non-inferior trastuzumab plasma levels. Overall, the safety profile in both arms of the HannaH study was consistent with that expected from standard treatment with Herceptin and chemotherapy in this setting.

Globally, breast cancer is the most common cancer among women. Approximately 1.4 million new cases of breast cancer are diagnosed worldwide each year. HER2-positive breast cancer, which is a particularly aggressive form, affects approximately 15-50% of women with breast cancer.

Roche's Herceptin is a humanised monoclonal antibody designed to target and block the function of HER2, a protein produced by a specific gene with cancer-causing potential when it is overexpressed. The mode of action of Herceptin activates the body's immune system and suppresses HER2 signalling to target and destroy the tumour.

The drug was first approved in 1998 and has been used to treat over 1.3 million patients worldwide since.