CHMP recommends EU approval of Roche’s Subcutaneous Herceptin for HER2 positive breast cancer

• New injectable administration takes two to five minutes, rather than 30 to 90 minutes with the current intravenous form, potentially saving both healthcare resources and patients’ time
• Herceptin® is a personalised medicine used to treat more than 80,000 HER2-positive breast cancer patients in Europe each year

Roche (SIX: RO, ROG; OTCQX: RHHBY) is pleased to announce that the European Union’s Committee for Medicinal Products for Human Use (CHMP) has today recommended EU approval of a subcutaneous formulation of Herceptin® (trastuzumab) for the treatment of patients with HER2-positive breast cancer. Since Herceptin’s first approval in 1998 this targeted medicine has been used to treat more than 1.3 million patients worldwide.

At present, Herceptin is given to patients intravenously, which takes 30 to 90 minutes per dose. By contrast, the new subcutaneous formulation of Herceptin can be administered in two to five minutes by a simple injection under the skin.¹

« Over the last 14 years, Herceptin has revolutionised the treatment of HER2-positive breast cancer. Today, more than 80,000 patients in Europe receive Herceptin each year,” said Hal Barron, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “EU approval of this subcutaneous form of Herceptin would provide a more convenient option for patients that potentially saves time and healthcare resources. »

The CHMP’s positive opinion was based on data from the pivotal phase III HannaH study which showed the efficacy and safety of the subcutaneous formulation of Herceptin were comparable to treatment with Herceptin administered intravenously.¹

The subcutaneous formulation of Herceptin uses technology developed by Halozyme Therapeutics, Inc. that reversibly breaks down hyaluronan, a gel-like substance that forms a barrier between cells under the skin. This enables the relatively large volume of the subcutaneous formulation of Herceptin to be rapidly dispersed over a greater area.

Roche is working with regulatory authorities around the world to ensure patients who are eligible for treatment with Herceptin have the option of choosing this more convenient therapy.

 

Source: Roche