FDA accepts Sanofi's sNDA for Eloxatin

The US Food and Drug Administration has accepted for filing and assigned priority review status to a supplemental New Drug Application that proposes changes to Sanofi-Aventis' Eloxatin (oxaliplatin injection) prescribing information to include a six-year analysis from the MOSAIC trial.

In the proposed PI changes, the French drug major 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.