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Company asks for new survival data on Eloxatin label

Company asks for new survival data on Eloxatin label

BRIDGEWATER, New Jersey—Sanofi-aventis’ supplemental New Drug Application for Eloxatin (oxaliplatin) has been accepted by FDA and assigned priority review status. The sNDA proposes changes to the Eloxatin prescribing information to include long-term survival data from the MOSAIC trial.

The company is seeking the inclusion of 6-year overall survival and 5-year disease-free survival data from the trial in stage III colon cancer patients treated with either FOLFOX4 (Eloxatin-based chemotherapy regimen) or standard infusional 5-FU/LV-based chemotherapy alone, following surgery.

A priority review designation sets the target date for the completion of FDA’s review of the proposed changes at or before 6 months from the date of filing.

In the MOSAIC trial, stage III colon cancer patients receiving Eloxatin-based therapy had a significant reduction (20%) in the risk of dying after a median of 6 years, compared with standard 5-FU/LV-based chemotherapy alone (HR 0.80, P = .023). Also, disease-free survival was improved by 22% in stage III patients (HR 0.78, P = .005).

The phase III MOSAIC study, conducted at 148 centers in 20 countries, included 2,246 patients with stage II or III colon cancer.

Based on MOSAIC, in 2004 FDA approved Eloxatin in combination with infusional 5-FU/LV for the treatment of stage III colon cancer patients who have their primary tumors surgically removed. The primary endpoint was disease-free survival at 3 years, with overall survival as a secondary endpoint. At the time of the original analysis, with 4 years’ median follow-up, there was no demonstrated overall survival benefit.

 

 
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