Cell Therapeutics receives feedback regarding proposed filing of MAA for pixantrone

NewsGuard 100/100 Score

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.

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment
Post

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
Scientists map all yeast proteins across cell cycle for the first time