Seattle-based Cell Therapeutics (CTI) has taken another step towards gaining European approval for its new treatment for non-Hodgkin’s lymphoma.
CTI said one of the last pieces in the puzzle which will allow them to begin marketing pixantrone has been validated by the European Medicines Agency (EMEA), and takes them one step further to marketing the drug across the continent later this year.
The validation of the expanded Paediatric Investigation Plan (PIP) that was filed in July allows the company to begin looking further ahead to rolling out pixantrone for use in patients with relapsed or refractory aggressive non-Hodgkin’s lymphoma who have failed two or more previous therapies.
CTI said the PIP will study the safety and effectiveness of the drug compared to doxorubicin in paediatric lymphoid cancers.
Jack Singer, chief medical officer at CTI, said: “We are very pleased that the EMEA has validated the expanded PIP for pixantrone, as there is a real need for a less toxic, more effective anthracycline-like treatment option not only in lymphoma, but also possibly in other tumours.”
Following the programme’s approval, CTI will submit the Marketing Authorisation Application for the drug’s European use later this year.
Copyright Press Association 2010