Roche has announced that a new injectable (subcutaneous) formulation of Herceptin (trastuzumab) has been approved by the European Commission for the treatment of HER2-positive breast cancer, an aggressive sub-type of the disease. The 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,” said Hal Barron, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “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.”
Research shows that maintaining a normal life and spending time with friends and family can improve the wellbeing of women with breast cancer. The new formulation may reduce the amount of time patients spend in hospital receiving treatment with Herceptin as it can be administered at least six times faster than the standard intravenous form.
The European Commission’s approval was based on data from the HannaH study 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. No new safety signals were identified.