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New injectable version of Roche breast cancer drug approved by EMA
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ZURICH (Reuters) - Swiss drugmaker Roche said on Friday that European regulators had given a green light to a new formulation of its breast cancer drug Herceptin, which it hopes will help extend the medicine's shelf life.
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The European Medicines Agency (EMA) said that its experts had recommended approval of a new injectable version of Herceptin, which cuts down treatment time to just two to five minutes. It currently takes between 30 to 90 minutes to administer the drug intravenously.
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Herceptin, known generically as trastuzumab, is used as a treatment for around a quarter of breast cancer patients who have tumors that generate a protein called HER2, which tends to make their disease more aggressive.
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Recommendations for marketing approval by the agency's Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months.
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