Eloxatin

Cancers of the colon and rectum (colorectal) are the fourth most commonly diagnosed cancers and rank second among cancer deaths in the United States.

The FDA has approved Eloxatin (oxaliplatin) injection for use with infusional 5-fluorouracil (5-FU) plus leucovorin. The combination treats people with colorectal cancer whose disease has recurred or become worse following initial therapy with a combination of irinotecan with bolus 5-FU plus leucovorin.

The combination with Eloxatin was shown to shrink tumors in some people and delay resumed tumor growth. There are no data yet on the effects of the combination on survival.

The FDA reviewed the marketing application for Eloxatin in seven weeks--the fastest review to date for a cancer drug. The agency was able to review and approve the drug rapidly because of "rolling review" procedures available under new drug applications that are designated as "fast track." Drugs in development that have the potential to be an advance in treatment for serious illness may be identified as "fast track" drugs. Under this designation, rolling applications allow for the submission of some parts of the application before remaining sections are submitted.

Eloxatin is intended for use by physicians experienced in the use of cancer agents. A warning boxed in black for emphasis, details this use and highlights reactions associated with the drug.

Eloxatin can have a toxic effect on nerve endings that may result in either an acute or cumulative pattern of side effects. This may cause the feeling of numbness or tingling, especially in the hands and feet or around the mouth and throat. For some patients, these symptoms may be worsened by exposure to cold. Another side effect, which generally improves after treatment is complete, is difficulty performing ordinary daily tasks such as buttoning clothes.

Other common side effects of Eloxatin are vomiting, diarrhea, anemia, increased risk of bleeding or infection, or allergic reaction. Women should be advised to avoid becoming pregnant while receiving this treatment because it may harm the fetus.

Eloxatin will be distributed by Sanofi-Synthelabo, Paris.

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