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It's the 'Fast Track' for a new cancer drug.

The U.S. Food and Drug Administration (FDA) recently gave its "fast track" approval, initially reserved for new AIDS drugs, to Eli Lilly and Company's experimental anticancer drug, Gemzar. The FDA program, begun in 1987, allows seriously ill patients to obtain promising new drugs before they have been fully tested.

Lilly will provide Gemzar free of charge to patients with pancreatic cancer who are not suitable candidates for surgery. Pancreatic cancer, which killed actor Michael Landon, is particularly deadly. Most of its victims die within four months of diagnosis because its presence is not usually detected until it has spread into the many adjacent lymph nodes and organs.

Cancer is essentially a disease of cells that have gone bad and run amuck. All organs and other body tissues are constantly producing new cells to replace those lost through normal wear and tear. Sometimes abnormal changes (mutations) appear in a particular type of cell, and these cells then grow uncontrollably, destroying adjacent tissue and spreading to other parts of the body. Death occurs when vital organs attacked by the cancer can no longer function effectively.

Gemzar fights cancer by inhibiting the formation of DNA, the substance in every cell that acts as a pattern for new cells and regulates their growth. Without DNA, a cell cannot multiply. Gemzar also seems to act selectively on cancer cells without seriously affecting adjacent normal cells.

The standard treatment for pancreatic cancer has been another DNA-antagonist, 5-fluorouracil (5-FU), one of a number of similar drugs used to treat various forms of cancer. Although Gemzar was able to prolong life only six weeks more on average than 5-FU, 18 percent of patients receiving Gemzar were still alive after one year, compared to only 2 percent of those on 5-FU.

Although not a cure for pancreatic cancer, Gemzar slows the progression of the disease and improves the quality of the patient's life by reducing pain and other symptoms. Because of its selective action on cancer cells, it produces fewer side effects than most anti-cancer drugs. Overall, the relative success of Gemzar may not seem impressive. To those dying of this especially deadly form of cancer, however, it brings welcome, albeit temporary, relief - and to all of us the renewed hope of total victory in the battle against cancer.
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Title Annotation:fast FDA approval for experimental drug Gemzar
Publication:Medical Update
Date:Apr 1, 1995
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