Apr 19 2010
Cell Therapeutics, Inc. (Nasdaq and MTA: CTIC) (the "Company") today announced that it met with and received feedback from the rapporteurs and the European Medicines Agency's (the "EMEA") medical reviewers regarding a proposed filing of a Marketing Authorization Application ("MAA") for pixantrone in the European Union to treat relapsed/refractory aggressive non-Hodgkin's lymphoma ("NHL"). The rapporteurs, who are assigned by the EMEA, are responsible for providing scientific advice on the evaluation of medicinal products. The feedback was supportive of filing on the basis of the PIX301 trial and the Company expects to submit the MAA in September 2010.
"Both the rapporteurs and medical reviewers felt that the totality of the efficacy data from the PIX301 trial including the complete response rate, overall response rate, progression-free survival and the trend in overall survival supports a MAA submission and review," said Jack Singer, M.D., Chief Medical Officer of the Company. "Relapsed/refractory aggressive NHL beyond second line therapy represents a significant unmet medical need in European Union and pixantrone has been granted orphan drug status in this indication. We will work diligently to move the application forward as quickly as possible," Singer added.
SOURCE Cell Therapeutics, Inc.
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