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 beside colorectal cancer whose disease has recur or become worse following initial therapy next to a combination of irinotecan with bolus 5-FU and leucovorin. The combination including Eloxatin be shown to shrink tumors in some patients and delay resumed tumor growth. There are as even so 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 be able to review and approve this drug so hurriedly because the agency utilized the "rolling review" procedures that are available under clean drug applications designated as "Fast Track." Drugs in nouns that have the potential to be an mortgage in treatment for a serious syndrome 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 section are completed and submitted to the agency. For Eloxatin, the first piece of the rolling application was submitted on April 15, 2002, and the closing portion on June 24, 2002.
"Patients diagnosed with colorectal cancer will presently have access to another treatment opportunity for this disease," said Health and Human Services Secretary Tommy G. Thompson. "I want to commend FDA for reviewing the drug's safety and usefulness so quickly."
A multi-center, randomized, controlled study compared the worth 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 have either relapsed, or progressed while on or shortly after standard treatment. Although the individual drugs have very little effect, the combination resulted in a greater number of patients have tumor shrinkage and led to a rearrangement In resumption of cancer growth.
"Even though long-term benefits such as increased survival have not nonetheless been demonstrated," said Dr. Lester M. Crawford, FDA Deputy Commissioner, "untimely studies have shown that Eloxatin may hold significant benefit for many patients."
Eloxatin is intended for use by physicians experienced in the use of cancer agents. A black box restrictive detailing this use and highlighting anaphylactic-like reactions associated beside Eloxatin is included in the labeling. Eloxatin can have a toxic effect on boldness endings that may result contained by either an acute or cumulative shape of side effects. This may result in the consciousness of numbness or tingling, especially in the hands or foot or around the mouth or throat. For some patients these symptoms may be worsened by exposure to cold. This side effect usually occurs inwardly hours or days of dosing. Another side effect is impairment in performing ordinary day by day tasks such as difficulty buttoning clothes. This condition generally improve after the treatment is complete.
Other common side effects of Eloxatin are vomiting, diarrhea, anemia, increased risk of bleeding or infection, or allergic criticism. Women should be advised to avoid becoming pregnant while unloading this treatment, because it may cause harm to the fetus.
Cancers of the colon and rectum (colorectal) are the fourth most commonly diagnosed cancer and rank second among cancer death in the United States. About 150,000 hot cases of these cancers materialize each year, and they explanation approximately 56,000 deaths.
Exloxatin be developed and will be distributed by Sanofi-Synthelabo.
Additional Eloxatin Information
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