Company expects to obtain approval/launch the drug in the U.S. by the 4Q2009; rolling NDA submission began 4/09; positive Phase III data showed significant increases in the remission rates of patients with non-Hodgkin's lymphoma 6/09; NDA submission completed and priority review requested 6/09; NDA accepted by FDA 8/09; positive phase III data to be submitted with 120day update to NDA (10/09); PDUFA date 4/23/2010 and FDA advisory board date 2/10/2010; FDA postpones advisory board due to weather, but reviewers raise concern about power of study, as well as cardiac/hematologic toxicity (2/10); FDA advisory board unanimously rejects drug in 9-0 vote, over concern of inadequacy/execution of trial (3/10); FDA approves manufacturing facility (3/10); FDA rejects drug in an unanimous vote, based on concerns regarding effectiveness and enrollment of half of the patients expected; FDA is requiring an additional trial (4/10); data from pivotal trial showed patients who achieved a complete response (CR)/unconfirmed complete response (CRu) to Pixuvri had up to a 63% probability of being alive at 24 mo vs. 20% comparitors; 21% improvement in overall survival for Pixuvri (6/10)
Brand Pixuvri Generic pixantrone
Company name Cell Therapeutics Product type Speciality
Therapeutic category Antineoplastics Key uses non-Hodgkin's lymphoma (NHL), refractory indolent
Other Uses Multiple sclerosis Drug Class mitoxantrone analog, anthracenedione
Dosage From IV Expected Approval 2012+
FDA Filing 4/09 Last Update date August 18,2010
Link to news article
Link to clinicaltrials.gov
Link to press releases