Pixuvri pixantrone regulatory update

Cell Therapeutics said the Pediatric Committee (PDCO) of the European Medicines Agency (EMA) issued a positive opinion agreeing to the company's pediatric investigation plan (PIP) for Pixuvri pixantrone to treat lymphoid malignancies and solid tumors in children ages 6 months to 18 years. The PIP is part of a planned MAA submission in the EU for Pixuvri to treat relapsed or refractory, aggressive non-Hodgkin's lymphoma (NHL) (see BioCentury, July 19). Cell Therapeutics plans to submit the MAA later this quarter. ...