Cell Therapeutics has withdrawn its European application to market lung cancer drug Opaxio. In announcing the setback earlier this week, the company cited the concerns of an EMEA committee regarding its trial design. CTI had expected to gain approval to market the drug by early 2011.
The developer said it will now focus its resources on an ongoing Phase III trial evaluating Opaxio as a maintenance therapy for ovarian cancer, as well as exploring the drug as a radiation sensitizer for advanced esophageal cancer treatments. Also in the pipeline is pixantrone, which is now under FDA review for relapsed non-Hodgkin's lymphoma. CTI codevelops Opaxio with Novartis, which also has the option to license pixantrone.
The company's stock fell 3 percent in afternoon trading.
- here's CTI's release on Opaxio
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