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news.Sanofi-Aventis has said that the FDA has accepted for filing and assigned priority review status to a supplemental new drug application that proposes changes to the Eloxatin prescribing information.
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In the proposed PI changes, company is seeking the inclusion of six-year overall survival and five-year disease free survival data 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 to remove the primary tumor.
A priority review designation sets the target date for the completion of the FDA’s review of the proposed changes at or before six months from the date of filing.