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Halozyme Therapeutics Inc Announces Roche Holding AG Receives Marketing Authorization for Herceptin SC in European Union


Monday, 2 Sep 2013 01:05am EDT 

Halozyme Therapeutics Inc announced that the European Commission has granted Roche Holding AG European Union (EU) marketing authorization for the use of a time-saving subcutaneous (SC) formulation of Herceptin (trastuzumab) for the treatment of HER2-positive breast cancer. This formulation utilizes Halozyme's recombinant human hyaluronidase (rHuPH20) and is administered in two to five minutes, rather than 30 to 90 minutes with 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.1 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. 

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