The decision was based in part on the agency’s guidance that a primary endpoint analysis of less than the initially-projected 320 eligible patients could be acceptable for new drug application submission if it is able to demonstrate a statistically significant difference between treatment arms.
In addition, the FDA agreed that randomized safety data from the RAPID study could be used to support the EXTEND results in an NDA submission for pixantrone. Based on this guidance the company currently anticipates completing enrollment in the EXTEND trial in the fourth quarter of this year with primary endpoint data and final results being reported in the first half of 2008. Pixantrone has received Fast Track status from the FDA for this indication.
James Bianco, president and CEO of CTI, said: “Going straight to a final analysis will allow us the potential to submit an NDA for pixantrone and receive approval in 2009. The inclusion of safety data from the randomized trial of pixantrone versus doxorubicin is also a very important recognition of the potential toxicity benefit of this novel agent.”