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news.The FDA has accepted for filing Xanthus Pharmaceuticals's new drug application for fludarabine phosphate oral tablets for the treatment of relapsed B-cell chronic lymphocytic leukemia.
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The company said that the filing of the new drug application (NDA) indicates that the registration package is sufficiently complete to allow for a thorough review of the data supporting the safety profile and effectiveness of oral fludarabine.
Richard Dean, CEO of Xanthus, said: “Currently patients with chronic lymphocytic leukemia undergoing fludarabine treatment in the US receive the drug intravenously. Acceptance of the NDA application is a critical next step in our effort to provide these individuals with a more patient-friendly delivery option. With the convenience of oral dosing and a strong body of clinical efficacy and tolerability data already behind it, we believe oral fludarabine represents an exciting opportunity for Xanthus.”