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Roche runs for EU application of subcutaneous Herceptin

26.03.2012

Basel/Vienna - Following promising results from a Phase III study, Roche has submitted a regulatory application to EMA for subcutaneous Herceptin (trastuzumab) to treat HER2-positive breast cancer. Roche said subcutaneous administration of Herceptin is less invasive and more convenient to patients, as it takes approximately five minutes instead of 30-90 minutes with the approved intravenous (IV) administration. The regulatory application is based on data from the Phase III HannaH trial presented on March 23 the at the European Breast Cancer meeting in Vienna. Subcutaneous Herceptin produced a complete pathologic response rate, the co-primary endpoints of pharmacokinetics and efficacy met their pre-specified criteria. The drug concentration in the blood measured just before surgery was at least as high for the SC as for the IV formulation (69.0 and 51.8 µg/mL, respectively). This is important in order to demonstrate comparable efficacy. In addition, efficacy, determined by pCR, in patients treated in the SC arm was in the same range as in patients who received the IV formulation (45.4 percent and 40.7 percent, respectively). Subcutaneous Herceptin is formulated using Enhanze recombinant human hyaluronidase (rHuPH20) drug delivery technology from Halozyme Therapeutics Inc.

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London – The European Medicines Agency (EMA) calls it “the biggest change to the legal framework since the establishment of the Agency in 1995.” This year, the EU drug regulators are preparing new so-called pharmacovigilance...

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Norway’s Algeta ASA (Oslo) has updated its Phase III survival analysis of Alpharadin in patients with castration-resistant prostate cancer and bone metastases. The analysis showed an increase of 3.6 months in median overall...

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The share value of French specialist for cardiometabolic diseases Genfit S.A. (Loos/Lille) took a jump after the company announced its candidate drug GFT505 had met all efficacy endpoints in a pilot Phase II study involving 22...

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The US Food and Drug Administration (FDA) has granted a Biologics License Application (BLA) to the HER2 dimerisation inhibitor pertuzumab developed by Roche (Basel) for previously untreated HER2­-positive metastatic breast...

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A For years, the world’s major patent offices – including the EPO, USPTO and JPO – have been collaborating in the Patent Prosecution Highway (PPH) programme. Under the PPH, an applicant whose claims have been allowed in one...

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A Brussels – The European Commission is boosting its investments and policy activities to foster sustainability. “Europe needs to make the transition to a post-petroleum economy,” said Máire Geoghegan-Quinn in Brussels. In...

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Brussels – In February, I heard of a slightly mad and very worrying trend in decisions handed down by the Court of Justice of the European Union (CJEU) with regard to IP issues handed up from the national level for clarification....

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