Avastin QoL Data In First-Line Glioblastoma Muddy Expansion Plans
Genentech’s bevacizumab was associated with improved maintenance of baseline quality of life and performance status in a confirmatory trial conducted under accelerated approval, but an NCI-funded study found higher rates of neurocognitive decline, increased symptom severity and decline in health-related quality of life.
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Agency favors symptom-focused assessments over global quality-of-life evaluations when considering whether the data can support a drug labeling claim for use in treating pediatric cancer. Measures used for EU reimbursement considerations are usually not sufficient for FDA labeling claims, official cautions.