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National Cancer Institute
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Newly Approved Cancer Treatments
    Updated: 08/20/2004
Introduction

Included here are brief descriptions of therapies that have been newly approved for the treatment of cancer by the U.S. Food and Drug Administration (FDA 1). The FDA is the division of the U.S. Department of Health and Human Services charged with ensuring the safety and effectiveness of new drugs and other products. (See "Understanding the Approval Process for New Cancer Treatments 2.") The FDA's mission is to promote and protect the public health by helping safe and effective products to reach the market in a timely way, and monitoring products for continued safety after they are in use.

Sometimes the therapies listed here will be brand new. Other times, therapies already approved for one use will have received FDA approval for specific, newly documented uses ("indications") in the treatment of cancer.

The summaries are provided by Richard Pazdur, M.D., director of the FDA's Division of Oncology Drug Products, and Patricia Keegan, M.D., director of the FDA's Division of Clinical Trials Design and Analysis. Each summary includes a link to the complete product label, which provides clinical information on the indication, contraindications, dosing and safety of the product.

For further information related to oncology drug approvals, regulatory information and other oncology resources, please refer to the FDA's Oncology Tools 3 Web site.



Table of Links

1http://www.fda.gov
2http://cancer.gov/clinicaltrials/learning/approval-process-for-cancer-drugs
3http://www.fda.gov/cder/cancer