Cell Therapeutics, Inc. (Nasdaq and MTA: CTIC) (the "Company") today announced that it had received a Complete Response Letter from the U.S. Food and Drug Administration (the "FDA") regarding its New Drug Application ("NDA") for Pixuvri™ (pixantrone dimaleate) for relapsed or refractory aggressive non-Hodgkin's lymphoma ("NHL"). The FDA cited as its primary reason for the action its concerns previously raised at the Oncologic Drugs Advisory Committee ("ODAC") meeting on March 22, 2010 and recommended the Company conduct an additional trial to demonstrate the safety and effectiveness of its product. Based on the FDA's ODAC presentation, which provided the Committee and the Company with alternative options to consider to make investigational drugs available to patients if drugs need to be studied further prior to approval, the Company has decided to pursue expanded access program for pixantrone while it conducts an additional study in aggressive NHL.
"On the basis of discussing the PIX 301 clinical trial results with directors of more than 50 of the largest academic and community based lymphoma treatment centers across the U.S., we expect enrollment in a follow-up combination therapy study in a similar population could be rapid and occur predominantly within the U.S.," noted Jack W. Singer, M.D., Chief Medical Officer of the Company. "We have had preliminary discussions on the subsequent trial design with a leading statistician, and potential lead investigators who believe the study will be positively received by the lymphoma treatment community on the basis of the PIX 301 clinical trial results and the lack of satisfactory alternative therapies for their patients with multiple relapsed aggressive non-Hodgkin's lymphoma."
"This is a sad outcome for our patients with relapsed/refractory aggressive NHL," said Dr. Stanley M. Marks, Director of Clinical Services and Chief Medical Officer for the University of Pittsburgh Cancer Centers ("UPMC") and Chief of the Division of Hematology/Oncology at UPMC. "I was disappointed that an agency charged with providing treatment hope for patients with life threatening diseases like relapsed/refractory NHL would ignore clinically meaningful improvements in overall response rate and progression-free survival, let alone complete responses, something we all wish for our patients, but with existing treatments rarely achieve."
The Company plans to request a meeting with the FDA on both the design of the follow-on study as well as expanded access program for patients who are not participating in the Company's clinical trial.
Later this month, the Company is scheduled to meet with its clinical expert and the co-rapporteurs as it prepares to submit its Marketing Authorization Application ("MAA") to the European Medicines Agency ("EMEA") for review. Based on their feedback and guidance, the Company expects to submit the application in the third quarter of 2010.