EMA: bevacizumab in breast cancer only in combination with paclitaxel
bevacizumab (Avastin) for the treatment of breast cancer in the future may only be used in combination with paclitaxel.
bevacizumab (Avastin), which was approved in the EU so far include the first-line treatment of metastatic breast cancer in combination with paclitaxel or docetaxel, may in future only with paclitaxel be used. The decision by the European Commission is based on a recommendation of the Committee for Human Medicinal Products of the EMEA (CHMP), who had performed in 2010 to reassess the risk-benefit ratio for this combination therapy. Here, the risk-benefit ratio for the combination of bevacizumab plus paclitaxel was still positive, the combination of bevacizumab plus docetaxel, however, been rated negatively.
In the United States intends to bevacizumab FDA approval for breast cancer, where bevacizumab is used in combination with paclitaxel escape, complete.
The Drug Commission of the German Medical Association - had already in 2008, press releases critical of the approval for bevacizumab expressed in combination with paclitaxel in metastatic breast cancer and shares the concerns of the FDA. From the perspective of AkdÄ should be approved in Europe continues to be used combination with paclitaxel in breast cancer, therefore, extremely cautious. The affected patients should be advised of the expected marginal benefit and the rare but serious side effects before an individual decision is made for this treatment option.
Source:
ABDA databases: report of 3 March 2011
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