The US FDA and European Union
Although it is yet to be seen what the European Medicines Agency will make of Kite Pharmaceutical's axicabtagene ciloleucel, the United Stated Food and Drug Administration has already deemed it as a breakthrough therapy for the treatment of DLBCL, TFL, and PMBCL. It also has attained PRIME status, which means priority medicines, of regulatory support from the European Union. This massive amount of support from both the United States Food and Drug Administration and the European Union won't go unnoticed. Having such accolades will support its development and likely act as a catalyst to its regulatory review.
The USFDA is currently reviewing Kite Pharmaceutical's BLA, or biologics license application, for axicabtagene ciloleucel in treating refractory aggressive non-Hodgkin's lymphoma, which is another significant move forward for the treatment. For more information, the USFDA will be releasing their results and final decision as per their Prescription Drug User Fee Act, or PDUFA, date of November 29. Therefore, significantly more information about axicabtagene ciloleucel is promised to be available by the end of November.