CTI Appeals FDA’s Rejection of Pixantrone for Lymphoma

Cell Therapeutics (CTI) believes the FDA erred in denying its NDA for pixantrone to treat patients with relapsed or refractory, aggressive non-Hodgkin’s lymphoma, saying its single clinical trial of the drug met all primary and secondary endpoints in the patient population. CTI plans to file an appeal in the next few under the FDA’s formal dispute resolution process, spokesman Dan Eramian said.
Washington Drug Letter