Genentech’s bevacizumab was the subject of one study supporting use in cervical cancer and one failing to show an effect in first-line brain cancer. A separate study repeated the disappointing brain cancer results, but the sponsor sees a silver lining in the quality of life dataset.
CHICAGO – With the failure of Avastin to improve overall survival in a pair of studies in first-line glioblastoma, Roche/Genentech Inc. is again in the position of taking discordant confirmatory data to FDA in support of an accelerated approval, only this time they may have support from quality-of-life data.
Two separate studies looking at Avastin (bevacizumab) in first-line glioblastoma multiforme were presented at the American Society of Clinical Oncology...
A draft international guideline on using adaptive trial designs says sponsors should provide a clear rationale for using such designs to address the potential ‘tension’ between the confirmatory nature of late-stage trials and the flexibility introduced by mid-trial adaptations.
Denmark is shaking up clinical trial timelines with a new process for reviewing applications for early-phase mono-national trials that is twice as fast as the standard timelines in the EU and the UK.
HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.
