Plus   Neg

CTI To Withdraw European Marketing Authorization Application For Pacritinib

CTI BioPharma Corp. (CTIC) announced the company will withdraw its European Marketing Authorization Application for pacritinib as a treatment for myelofibrosis. The CHMP was likely to formally adopt a negative opinion in its evaluation of the application, CTI stated. The CHMP indicated that the risk-benefit profile for pacritinib for the intended indication has not been sufficiently established with the clinical data available to date.

The company said it is continuing to develop pacritinib for both U.S. and European registration as a treatment for myelofibrosis patients with severe thrombocytopenia. CTI plans to seek scientific guidance from the EMA before beginning the planned Phase 3 study.

CTI BioPharma announced that on January 23, 2019, a planned third interim review of the PAC203 study was held by the Independent Data Monitoring Committee and the study will continue as scheduled.

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