The drug has been approved for use in combination with infusional 5-fluorouracil (5-FU) and leucovorin. It is to be used in patients whose disease has recurred or become worse following initial therapy with a combination of irinotecan with bolus 5-FU and leucovorin.
The combination including oxaliplatin 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 oxaliplatin in 7 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 oxaliplatin, the first piece of the rolling application was submitted on 15 April 2002, and the last portion on 24 June 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.
| FDA reviewed the marketing application for oxaliplatin in 7 weeks.
"I want to commend FDA for reviewing the drug's safety and effectiveness so quickly."
A multicenter, randomized, controlled study compared the effectiveness and safety of oxaliplatin alone, infusional 5-FU/leucovorin alone, and the combination of these 2 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, early studies have shown that oxaliplatin may have significant benefit for many patients," said Dr Lester M. Crawford, FDA Deputy Commissioner.
A black box warning detailing the use and highlighting anaphylactic-like reactions associated with oxaliplatin is included in the labeling.
The FDA notes that oxaliplatin 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.
Other common side effects of oxaliplatin 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.