FDA APPROVES ELOXATIN FOR COLORECTAL CANCER

The Food and Drug Administration (FDA) today announced the approval of Eloxatin (oxaliplatin) injection for use in combination with infusional 5-fluorouracil (5-FU) and leucovorin for the treatment of patients with colorectal cancer whose disease has recurred or become worse following initial therapy with a combination of irinotecan with bolus 5-FU and leucovorin. The combination including Eloxatin was shown to shrink tumors in some patients and delay resumed tumor growth. There are as yet no data on the effects of the combination on survival.

FDA reviewed the marketing application for Eloxatin in seven weeks, the fastest review to date for a cancer drug. FDA was able to review and approve this drug so rapidly because the agency utilized the "rolling review" procedures that are available under new drug applications designated as "Fast Track." Drugs in development that have the potential to be an advance in treatment for a serious illness may be identified as "Fast Track" drugs. Under this designation, rolling applications allow for the submission of some components of the application before the remaining sections are completed and submitted to the agency. For Eloxatin, the first piece of the rolling application was submitted on April 15, 2002, and the last portion on June 24, 2002.

"Patients diagnosed with colorectal cancer will now have access to another treatment option for this disease," said Health and Human Services Secretary Tommy G. Thompson. "I want to commend FDA for reviewing the drug's safety and effectiveness so quickly."

A multi-center, randomized, controlled study compared the effectiveness and safety of Eloxatin alone, infusional 5-FU/leucovorin alone (a standard type of treatment for colorectal cancer), and the combination of these two treatments in patients who had either relapsed, or progressed while on or shortly after standard treatment. Although the individual drugs had very little effect, the combination resulted in a greater number of patients having tumor shrinkage and led to a delay in resumption of cancer growth.

"Even though long-term benefits such as increased survival have not yet been demonstrated," said Dr. Lester M. Crawford, FDA Deputy Commissioner, "early studies have shown that Eloxatin may have significant benefit for many patients."

Eloxatin is intended for use by physicians experienced in the use of cancer agents. A black box warning detailing this use and highlighting anaphylactic-like reactions associated with Eloxatin is included in the labeling. Eloxatin can have a toxic effect on nerve endings that may result in either an acute or cumulative pattern of side effects. This may result in the feeling of numbness or tingling, especially in the hands or feet or around the mouth or throat. For some patients these symptoms may be worsened by exposure to cold. This side effect usually occurs within hours or days of dosing. Another side effect is impairment in performing ordinary daily tasks such as difficulty buttoning clothes. This condition generally improves after the treatment is complete.

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 cause harm to the fetus.

Cancers of the colon and rectum (colorectal) are the fourth most commonly diagnosed cancers and rank second among cancer deaths in the United States. About 150,000 new cases of these cancers occur each year, and they cause approximately 56,000 deaths.

Exloxatin was developed and will be distributed by Sanofi-Synthelabo.

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