BioCentury
ARTICLE | Clinical News

EMA grants CTI extension to respond to Day 120 questions for pacritinib

February 2, 2018 8:18 PM UTC

CTI BioPharma Corp. (NASDAQ:CTIC) said EMA's CHMP granted it a three month extension to submit responses to a Day 120 list of questions regarding its MAA for pacritinib (BAX 2201, ONX 0803, SB1518) to treat myelofibrosis in patients with thrombocytopenia.

CTI received the list in November. It includes major objections related to pacritinib's efficacy and safety, the size of the data set for the candidate and pharmacokinetic analyses from the Phase III PERSIST-2 trial. The company plans to submit a response in May and will include pharmacokinetic data from the ongoing Phase II PAC203 trial of pacritinib to treat primary myelofibrosis in patients who have failed prior treatment with Janus kinase-1 (JAK-1) and JAK-2 inhibitor Jakafi ruxolitinib...