CTI BIOPHARMA CORP. (NASDAQ:CTIC) Files An 8-K Other EventsItem 8.01.Other Events.
On January 25, 2018, CTI BioPharma Corp. (the “Company”) announced that the Company was granted a three month extension for submitting its response to the Day 120 List of Questions (D120 LoQ) from the Committee for Medicinal Products for Human Use (CHMP) of the EMA, with regard to the Marketing Authorization Application (MAA) for pacritinib. As a result of the extension, the Company anticipates submitting its response to the D120 LoQ by May 2018. The Company primarily requested the extension in order to provide the EMA with new pharmacokinetic analyses that include data from the ongoing phase 2 PAC203 study. The MAA was originally submitted to the EMA in June 2017 based on data from the PERSIST-2 phase 3 study. The Day 120 LoQ were received by the Company in November 2017 and included Major Objections in areas including efficacy, safety (including hematological, cardiovascular and infectious toxicities) and other concerns including the size of the data set and the pharmacokinetic analyses of the two dosing regimens studied in PERSIST-2. The extension request was submitted following a clarification meeting with the rapporteur and co-rapporteur and members of the EMA.
About CTI BIOPHARMA CORP. (NASDAQ:CTIC)
CTI BioPharma Corp. (CTI) is a biopharmaceutical company focused on the acquisition, development and commercialization of targeted therapies covering a spectrum of blood-related cancers to patients and healthcare providers. The Company is primarily focused on commercializing PIXUVRI in select countries in the European Union, for multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (NHL). It is also engaged in evaluating pacritinib for the treatment of adult patients with myelofibrosis. Its earlier stage product candidate, tosedostat, is an oral, once-daily aminopeptidase inhibitor that has demonstrated responses in patients with acute myeloid leukemia (AML). It also evaluates its pipeline candidate paclitaxel poliglumex (Opaxio), which targets solid tumors. It is evaluating Opaxio through cooperative group sponsored trials and investigator-sponsored trials (ISTs), such as the ongoing maintenance therapy trial in patients with ovarian cancer.