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Roche wins EU approval for injectable Herceptin

Can reduce cancer drug's administration time from 90 minutes to two minutes

Roche Basel Switzerland

The time taken to administer Roche's Herceptin to breast cancer patients in the EU is on course to be drastically cut after the European Commission (EC) approved an injectable form of the drug.

The 80,000 women who are treated with Herceptin each year in Europe currently take an intravenous form of Herceptin (trastuzumab), which can take between 30 and 90 minutes to administer in a hospital setting every week or every three weeks depending on the stage of breast cancer, causing significant disruption to a patient's day-to-day life.

The new formulation of the blockbuster therapy is a subcutaneous injection and can be administered six times faster, taking between two and five minutes for a patient to receive, resulting in a more convenient treatment for patients and freeing up time for healthcare professionals.

“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,” said Dr Hal Barron, Roche's chief medical officer and head of global product development.

As with the intravenous formulation, injectable Herceptin is only approved for breast cancer patients who overexpress the HER2 protein, which accounts for 15 to 20 per cent of breast cancer cases in women.

Roche developed subcutaneous Herceptin using recombinant human hyaluronidase technology developed by US-based biopharma company Halozyme Therapeutics.

This technology temporarily degrades a person's hyaluronan, which is a gel-like substance that forms a barrier between cells under the skin. By degrading hyaluronan, patients can receive Herceptin in its subcutaneous form that can be absorbed over a large area.

Clinical trials have demonstrated that this formulation of Herceptin has comparable efficacy and safety to intravenous Herceptin in women with HER2-positive early breast cancer.

The approval of the new version of Herceptin will give Roche a boost as it looks to make the most of its franchise before the drug's patent expiry in Europe in 2014, when cheaper biosimilar versions of the monoclonal antibody will start to compete for sales.

2nd September 2013

From: Sales



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