Inex/Enzon submit Onco TCS
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Inex/Enzon complete submission of Onco TCS (liposomal vincristine) March 15 for use as monotherapy in relapsed aggressive non-Hodgkin's lymphoma in patients previously treated with at least two combo regimens. Submission is based on the 119-patient, Phase II/III PIVOTAL (sPhingosomal Vincristine for the Treatment of Aggressive Lymphoma) study, which showed an overall response rate of 25% for the liposomal formulation. Results were presented at the American Society of Hematology in December 2003; median time to progression was three months overall and at least four months for responders. Inex initiated the rolling NDA Oct. 1 with submission of nonclinical safety and pharmacology data (1Pharmaceutical Approvals Monthly, Oct. 1, 2003, In Brief). Priority review is requested...