In April 2008, the European Medicines Agency (EMEA) accepted for review the company’s marketing authorization application (MAA) for Opaxio (paclitaxel poliglumex, CT-2103) for first-line treatment of patients with non-small cell lung cancer (NSCLC) with ECOG (Eastern Cooperative Oncology Group) performance status 2 (PS2).
The EMEA’s review process generally takes 15 to 18 months; if the MAA is approved by the EMEA at the end of its review, the company will be authorized to begin selling Opaxio in the European Union.
Jim Fong, vice president of commercial operations for Cell Therapeutics, said: “This is a key step toward commercialization as we prepare for the potential introduction of this novel biologically enhanced chemotherapeutic in Europe, to establish Opaxio as the global brand name for paclitaxel poliglumex.”