Posted by Michael Wonder on 02 Feb 2019
CTI BioPharma receives results of the CHMP oral explanation for pacritinib in the treatment of myelofibrosis and provides development update
1 February 2019 - CTI BioPharma today announced that the Company will withdraw its European marketing authorisation application for pacritinib as a treatment for myelofibrosis.
The decision follows recent interactions with the EMA's 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.
