Cell Therapeutics, Inc. ("CTI") (NASDAQ and MTA: CTIC) announced today an update on the status and progress of its European marketing authorization application ("MAA") for Pixuvri. CTI is seeking a license to market Pixuvri in the E.U. for patients with relapsed or refractory aggressive non-Hodgkin's lymphoma ("NHL") who have failed two or more prior lines of therapy. CTI received the CHMP's day 180 list of outstanding issues, which unlike the day 120 letter, contained only one remaining major objection to CTI's MAA and items not deemed to be major issues. CTI plans on submitting its responses to the day 180 list of outstanding issues by December 19, 2011. If the responses satisfy the outstanding objection and the CHMP does not require an oral explanation a positive recommendation on the approval of Pixuvri could be made at the January 19th meeting of the CHMP.
"We believe we have made excellent progress working collegially with the E.U. rapporteurs on addressing items raised in the day 120 list of outstanding issues because we resolved all major objections other than the one major remaining objection in the day 180 letter," stated James A. Bianco, M.D, CEO of CTI.
To address the remaining major objection, the CHMP required that CTI provide a literature review of mechanisms of rituximab resistance and analyses that demonstrate the efficacy of Pixuvri in patients with prior rituximab treatment, as well as information to address some additional questions that were not deemed to be major issues and could be addressed by additional analyses of currently available data.
On November 29th CTI met with the rapporteurs and team members from the EMA for a clarification meeting at which CTI and its clinical expert presented the results of its literature review, additional supportive analyses regarding the efficacy of pixantrone across response rates and progression free survival in patients with prior rituximab treatment as well as its other proposed responses to the list of outstanding issues. Based on feedback at the meeting, CTI believes its day 181 response submission can resolve this last outstanding major clinical objection as well as the minor concerns.
The basis for the MAA submission was CTI's pivotal randomized trial, PIX301, which compared Pixuvri to other available single agent therapies in the treatment of patients with relapsed or refractory aggressive NHL who failed two or more prior lines of therapy—a patient population for which there are currently no approved effective therapies.
The MAA review process involves a series of interactions between the applicant and the CHMP review team. After 120 days following the acceptance of the MAA, the applicant receives a list of outstanding issues, including major objections to approval. Any remaining issues are provided to the applicant at day 180 in the review cycle. If major objections remain after the applicant provides responses to the day 180 list of outstanding issues, the CHMP may request an oral explanation to address those remaining major objections. If major objections are adequately addressed in the applicant's day 180 response submission, then the CHMP can determine the approvability of the MAA without requiring an oral explanation. CTI is required to submit its day 181 responses to the day 180 list of outstanding issues by December 19, 2011 unless CTI deems it requires more time and requests an extension. At present CTI believes it will have all the requisite information and analyses to address all of the outstanding issues.
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