Roche reports positive study of Herceptin given by subcutaneous injection

Roche announced that the phase 3 HannaH study demonstrated comparable efficacy of a new, investigational subcutaneous (SC) formulation of Herceptin (trastuzumab) to the standard intravenous (IV) infusion of Herceptin in women with HER2-positive early breast cancer. The SC administration takes around 5 minutes to administer whereas the IV formulation (the current standard) takes around 30 minutes to infuse. Since the subcutaneous administration is an injection under the skin it may allow patients to spend less time in hospital receiving their treatment versus the intravenous method. The ready to use formulation may also significantly reduce pharmacy time as no medicine preparation time is required.

“Herceptin given by subcutaneous injection has the potential to offer patients an effective, more convenient delivery option for this proven medicine,” said Hal Barron, MD, Chief Medical Officer and Head, Global Product Development. “As a leader in innovative treatments for cancer, Roche is committed to a broad research program, including the development of new ways to administer our medicines.”

No new safety signals were observed and adverse events were consistent with Herceptin IV. Data from the study will be submitted for presentation at an upcoming medical meeting and will support a marketing application to regulatory authorities in the European Union.