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...
You may also be interested in...
Inex initiates Onco TCS
Inex begins rolling NDA submission Oct. 1 for its non-Hodgkin's lymphoma agent Onco TCS (liposomal vincristine) with nonclinical safety and pharmacology data. Remaining sections will be submitted before the end of the year. The firm is seeking an indication for relapsed aggressive NHL, but is also studying the agent in first-line NHL, relapsed small cell lung cancer, relapsed Hodgkin's disease, and others...
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.