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ImClone Systems And Bristol-Myers Squibb Announce Revisions To ERBITUX(R) (cetuximab) U.S. Product Labeling For Metastatic Colorectal Cancer
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company (NYSE: LLY), and Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved revisions to the U.S. prescribing information for ERBITUX® (cetuximab) concerning the treatment of patients with epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer (mCRC). The labeling revisions include a modification to the indication, which now includes a statement that retrospective subset analyses of metastatic or advanced colorectal cancer trials have not shown a treatment benefit for ERBITUX in patients whose tumors had K-ras mutations in codon 12 or 13 and that the use of ERBITUX is not recommended for the treatment of colorectal cancer with these mutations. Revisions concerning the use of ERBITUX in colorectal cancer tumors with K-ras mutations were also made to the clinical studies and clinical pharmacology sections of the product"s prescribing information.
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Swine Flu Update - Issued Wednesday 24 June 2009
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Sexual Transmission Of HIV Prevented By New Contraceptive Device
Researchers from Weill Cornell Medical College have published results showing that a new contraceptive device may also effectively block the transmission of the HIV virus. Findings show that the device prevents infection by the HIV virus in laboratory testing. The promising results are published in the most recent issue of the journal AIDS.
Diagnostics

Adult Cancer Survivors At Increased Risk Of Psychological Distress

Long-term survivors of cancer that developed in adulthood are at increased risk of experiencing serious psychological distress, according to a report in the July 27 issue of Archives of Internal Medicine, one of the JAMA/Archives journals. The estimated 12 million cancer survivors in the United States represent approximately 4 percent of the population, according to background information in the article. "The number of cancer survivors has steadily increased over the last three decades and is expected to continue to increase with the implementation of improved cancer screening, the adoption of more efficacious cancer treatment and the aging of the population," the authors write. "As more individuals survive cancer, it is important to understand how cancer and cancer therapies affect long-term quality of life and psychological adjustment." Karen E. Hoffman, M.D., M.H.Sc., of Brigham and Women"s Hospital and Dana-Farber Cancer Institute, Boston, and colleagues studied participants in the National Health Interview Survey, a cross-sectional in-person survey conducted annually by the U.S. Census Bureau. Participants in the 2002 to 2006 surveys were asked questions about their history of cancer and assessed using a scale of serious psychological distress. The researchers compared the responses of 4,636 individuals who had survived five years or longer following the diagnosis of an adult-onset cancer with those of 122,220 individuals who had never had cancer. A total of 5.6 percent of cancer survivors screened positive for severe psychological distress within the previous 30 days, compared with 3 percent of those without cancer. "After adjustment for other clinical and sociodemographic variables, long-term survivors who were younger, were unmarried, had less than a high school education, were uninsured, had more comorbidities or had difficulty performing instrumental activities of daily living were more likely to experience serious psychological distress," the authors write. A history of cancer may affect current mental health in several ways, the authors note. "Cancer diagnosis and treatment can produce delayed detrimental effects on physical health and functioning such as secondary cancers, cardiac dysfunction, lung dysfunction, infertility, neurological complications and neurocognitive dysfunction," they write. "A cancer history can also affect social adaptation, employment opportunities and insurance coverage. Adjusting to these functional and life limitations may create long-term psychological stress." A total of 9 percent of long-term cancer survivors and 6 percent of individuals without cancer reported seeing or talking to a mental health professional within the previous 12 months. One-third of survivors with serious psychological distress reported using mental health services, whereas 18 percent said they could not afford mental health care during the previous year. "Because long-term survivors may not be seen by oncologists as frequently as they were during treatment, or at all, the increased risk of serious psychological distress and the need to screen for serious psychological distress should be communicated to primary care physicians and other care providers," the authors conclude. "Given that cancer survivors with more chronic medical conditions tended to be those most at risk for psychological distress in this study, the findings also underscore the need to integrate medical and behavioral health care for survivors. Specifically, cancer survivorship clinics may benefit from having mental health providers on staff for a multidisciplinary approach to the care of these patients." Arch Intern Med. 2009;169[14]:1274-1281. Archives of Internal Medicine


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