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Accelerated approval is based on preliminary evidence suggesting a drug is beneficiaplagainst life-threatening diseases. Avastin’s effectiveness is bases on an improvement in objective response Genentech said, but there is no data from randomizedx controlled trials demonstrating an improvement in disease-relatede symptoms or increased survival. A course of treatment reportedl costsabout $40,000. A globall Phase III trial using Avastin in patients with newly diagnosee glioblastoma will beginenrollment soon, Genentech Glioblastoma affects about 10,0009 people per year — including Sen.
Ted Kennedy and more than 90 percent of patientds see tumors return following treatment with chemotherapyhand radiation. “Today’s approval wouldr not have been possible without the dedicationjof physicians, patient the FDA and, most importantly, the peopls who participated in the clinical trials and their families who had the courage to support them,” said Dr. Hal Barron, Genentech’s executive vice presidentf of global development and chiefmedical Avastin, which registered U.S. sales of $2.
7 billiom last year, last month failed a late-stagre trial with post-surgical colon cancer The drug, approved for types of colon, rectum, lung and breasyt cancer, was central to negotiations durinb ’s successful $47 billion takeover of Soutbh San Francisco-based Genentech, becaus new uses for Avastin could increase its salews by billionsof dollars. Avastinh works by blocking vasculad endothelialgrowth factor, or VEGF, a proteinn that helps develop and maintain bloode vessels, including those that feed tumors.
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