Cell Therapeutics' Dual Strategy On Pixuvri Will Be Tested At Advisory Committee

While appealing the “complete response” letter it got for its non-Hodgkin’s lymphoma treatment Pixuvri on the basis of re-analyzed data, Cell Therapeutics also is doing the additional combination trial the agency requested.

CTI BioPharma Corp. is pursuing an unusual two-track approach of both appealing a "complete response" letter for its investigative non-Hodgkin’s lymphoma treatment Pixuvri (pixantrone dimaleate) and complying with the request in that letter to conduct another clinical trial.

Pixuvri’s proposed indication is as a single-agent treatment for patients with relapsed or refractory, aggressive NHL who have received two or more prior lines of therapy. The Oncologic Drugs Advisory Committee will review the drug Feb

More from US FDA Performance Tracker

More from Regulatory Trackers