BRIEF—CTI BioPharma feedback on pacritinib from EMA

CTI BioPharma yesterday announced that the company has received a second round of questions related to the Day 180 List of Outstanding Issues, for the marketing authorization application (MAA) for pacritinib, from the European Medicines Agency.

The company plans to submit responses to the EMA, which will include data from the ongoing open label PAC203 trial, by the end of the year.

In addition, CTI BioPharma is preparing for an Oral Explanation meeting before the Committee for Medicinal Products for Human Use (CHMP).

A decision by CHMP on the MAA is expected in the first quarter of 2019.

Earlier this month, CTI BioPharma held a meeting with the US Food and Drug Administration about the regulatory pathway for experimental myelofibrosis drug pacritinib, which resulted in the agency calling for the company to conduct a Phase III clinical study for the drug, which it won’t be able to start until 2019, with that news causing a more than 40% slump in its share price.