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Kiadis completes end-of-Phase II meeting on Reviroc

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA has agreed that data from the completed Phase II trial of Kiadis Pharma's Reviroc supports moving the drug into Phase III, the company announces Dec. 19 after completing an end-of-Phase II meeting with FDA. Reviroc, used to eliminate cancer cells from autologous grafts in bone marrow transplants for end-stage blood cancer patients, improved overall survival in non-Hodgkin's lymphoma patients after transplantation in a Phase II trial. The Phase III trial will focus on patients with large B cell lymphoma and will be designed under a special protocol assessment with FDA...

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