CTI BioPharma Corp. will withdraw its application (MAA) to EMA for pacritinib as a treatment for myelofibrosis.
CTI BioPharma Corp. announced that the Company will withdraw its European Marketing Authorization Application (MAA) for pacritinib as a treatment for myelofibrosis.
The decision follows recent interactions with the European Medicine Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), during which the Company learned that the committee was likely to formally adopt a negative opinion in its evaluation of the application. 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.
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