The lowdown: All eyes were on the latest Phase III trial data for bevacizumab (Avastin; Genentech) in non-squamous, non-small-cell lung cancer, which showed an increase in median survival of 12.5 months on chemotherapy/Avastin compared with 10.5 months on chemotherapy alone. After 2 years, overall survival was 22% in patients given Avastin/chemotherapy compared with 17% on chemotherapy. Side effects still cast a shadow over Avastin: 5% of patients on Avastin had life-threatening bleeds, although only 1% died. Whether this is a consequence of, or independent from, Avastin's known effect of elevating blood pressure by inducing nitric oxide is still unknown. Positive results on Avastin were also presented for second-line metastatic colorectal cancer and breast cancer. Less positive were data from Novartis/Schering-Plough's multi-VEGF inhibitor PTK/ZK. Interim trial results on 1,168 patients failed to show a significant improvement in progression-free survival of colorectal cancer patients on PTK/ZK/FOLFOX chemotherapy versus FOLFOX alone. But 40% of PTK/ZK/ FOLFOX patients with a high level of the enzyme lactate dehydrogenase — which indicates the presence of tissue damage — did show significantly improved progression-free survival. Final results are expected in the second half of 2006.
The lowdown: The bill, sponsored by Senators Charles Grassley (R-IA) and Christopher Dodd (D-CT), would allow the new FDA office to impose fines on drug companies that fail to conduct certain studies, to order label warnings without discussion with companies and to review direct-to-consumer advertising. Companies that fail to conduct studies or meet deadlines for them would be fined US$250,000 for every 30 days of delay. FDA officials also announced measures for a Drug Safety Oversight Board, which would include members from various FDA offices, and would probably result in more Advisory Committee meetings. Critics maintain that this is not enough, but others ask whether plans to make drug safety evaluation independent from FDA's regular review procedures would lessen the priority of drug safety assessment within the normal agency's working practices.
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