© 2004 by Oxford University Press
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© 2004 Oxford University Press
NEWS |
In Brief
FDA Announces New Office of Oncology Drug Products
The U.S. Food and Drug Administration announced in mid-July the creation of a new Office of Oncology Drug Products, which is intended to "make the review process for cancer drugs stronger and more efficient," said Health and Human Services Secretary Tommy Thompson.
The office will result from changes in the organizational structure at the FDA that will consolidate three existing areas within the Center for Drug Evaluation and Research (CDER). The new office will be housed within CDER and will be responsible for evaluating drugs, biologics, and imaging procedures for cancer.
The final structure and responsibilities for the office are still under consideration. A national search for a director of the new oncology office will begin later this summer, and the implementation of the new office will occur when the FDA moves into its new facility in Silver Spring, Md., in April 2005.
Study Estimates Number of Deaths Prevented by Cervical Cancer Screening in England and Wales
A new study that models the effects of a national cervical cancer screening program in England and Wales estimates that the screening prevents 80% of the possible deaths from the cancer each year.
In the July 17 issue of The Lancet, Julian Peto, of Cancer Research U.K. in London, and colleagues reported that deaths from cervical cancer increased threefold between 1967 and 1987, largely because of increases in the prevalence of human papillomavirus (HPV)—the virus that causes cervical cancer—that accompanied changes in sexual behavior during that time. If this trend had continued, by 2030 about one in 65 women born since 1950 would die of cervical cancer, for a total of 5,500 deaths each year, according to the researchers.
However, since the national screening program began, the cervical cancer death rate has fallen to about 1,000 deaths each year and is expected to remain at that level. By 2030, approximately 4,500 deaths from cervical cancer would be prevented each year by the screening program.
The researchers calculated that screening costs about £36,000 ($67,000) for each life saved and £18,000 ($34,000) for each cancer prevented, compared with no screening.
Cetuximab for Advanced Colorectal Cancer Gives Months, but Cost High
A new study has found that treatment with a combination of cetuximab (Erbitux) and irinotecan (Camptosar) was more effective in patients with metastatic colorectal cancer than cetuximab alone. However, a related perspective article published with the study in the July 22 issue of the New England Journal of Medicine questions the usefulness of these results by considering the high cost of the therapies.
In a phase III trial, David Cunningham, M.D., of Royal Marsden Hospital in Surrey, England, and colleagues treated 327 patients with colorectal cancer that had progressed after treatment with an irinotecan-based regimen either with cetuximab alone or cetuximab plus irinotecan.
Patients who received the combination therapy had a higher response rate (22.9% versus 10.8% with cetuximab alone), greater median time to progression (4.1 versus 1.5 months), and a greater median survival time (8.6 versus 6.9 months), with only mild toxicity in both groups.
In a related perspective, Deborah Schrag, M.D., Ph.D., of the Memorial Sloan-Kettering Cancer Center in New York, compared the costs of conventional therapies with that of the cetuximab combination therapy, for which there is no evidence of cure. The cost of the drugs alone in the first 8 weeks of treatment with the combination therapy is $30,790, compared with just $63 for the Mayo Clinic regimen, the least expensive of the conventional treatments discussed.
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