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Advisory Committee Recommends Against Approval of Two New Cancer Drugs
An advisory committee to the U.S. Food and Drug Administration (FDA) last week recommended against the approval of two drugs for the treatment
of advanced melanoma and brain metastases, respectively. In both cases, the drugs' manufacturers had submitted applications for FDA approval
of their products based on the results of a single phase III clinical trial in which the drug did not achieve the trial's primary endpoint.
During its May 3 meeting, the FDA Oncologic Drugs Advisory Committee reviewed data on efaproxiral (RSR13), a "radiation sensitizer" intended to be used as an adjunct to radiation therapy to make it more effective, and oblimersen
(Genasense), part of a new class of "antisense" drugs thought to inhibit the production of proteins that protect cancer cells from treatments like radiotherapy
and chemotherapy.
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Providing Support for Children and Their Families
As we all are painfully aware, cancer can devastate a family. But as many of us have seen, those who have suffered through a bout with cancer or lost a loved one to cancer often respond by trying to help others like them.
Russ Sanford and his family fall into this group. In June 2002, 10-year-old Joe Sanford died after a courageous, 3-year fight with medulloblastoma,
a form of brain cancer that typically afflicts children and young adults. The Sanford family underwent the roller-coaster ride that all families do when one member battles cancer - treatment successes
and setbacks, periods
of calm, and periods of mania.
Read more
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This NCI Cancer Bulletin is produced by the National Cancer Institute (NCI). NCI, which was established in 1937, leads a national effort to eliminate the suffering and death due to cancer. Through basic and clinical biomedical research and training, NCI conducts and supports research that will lead to a future in which we can prevent cancer before it starts, identify cancers that do develop at the earliest stage, eliminate cancers through innovative treatment interventions, and biologically control those cancers that we cannot eliminate so they become manageable, chronic diseases.
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For more information on cancer,
call 1-800-4-CANCER or visit
http://cancer.gov.
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NCI Cancer Bulletin staff can be reached at ncicancerbulletin@mail.nih.gov.
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