Cell Therapeutics withdraws Opaxio application Print E-mail
By Staff and Wire Reports   
Wednesday, 23 September 2009 14:09
Cell Therapeutics (NASDAQ:CTIC) has withdrawn its European marketing application for its lung drug Opaxio, after an EU panel raised concerns over the trial design, Europe's drug regulator said on Wednesday.

The European Medicines Agency (EMEA) said it has received a letter from the Italian drugmaker saying that it has decided to withdraw the application after concerns were raised by European officials over how the clinical trials were designed.

The company had said that it expected to get approval to sell Opaxio, a drug to treat the most common type of lung cancer, by early 2011.

Cell Therapeutics, Inc. (Cell Therapeutics) develops, acquires and commercializes treatments for cancer.

It is developing OPAXIO (paclitaxel poliglumex), which was previously referred to as XYOTAX, for the treatment of non-small cell lung cancer (NSCLC), and ovarian cancer.




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