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Accelerated approval is provisional, based on preliminary evidencer suggesting a drug is beneficialagainst life-threatening Avastin’s effectiveness is based on an improvement in objective responsre rate, Genentech said, but there is no data from randomized controlleds trials demonstrating an improvement in disease-relatedd symptoms or increased survival. A course of treatmenr reportedly costsabout $40,000. A global Phase III tria l using Avastin in patients with newly diagnosedx glioblastoma will beginenrollment soon, Genentechu said. Glioblastoma affects about 10,000 people per year including Sen.
Ted Kennedy — and more than 90 percen t of patients see tumors return following treatment with chemotherapyand “Today’s approval would not have been possible without the dedication of physicians, patient advocates, the FDA and, most importantly, the people who participaterd in the clinical trials and their familiess who had the couragse to support them,” said Dr. Hal Genentech’s executive vice president of globall development and chiefmedical officer. Avastin, whichb registered U.S. sales of $2.
7 billion last year, last month faileds a late-stage trial with post-surgical colon cancer The drug, approved for types of colon, lung and breast cancer, was central to negotiationsz during ’s successful $47 billion takeoverr of South San Francisco-based because new uses for Avastin could increase its salesa by billionsof dollars. Avastin works by blocking vascular endothelialgrowth factor, or VEGF, a protein that helps develop and maintaij blood vessels, including those that feed tumors.
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