Dr. Pinilla-Ibarz on the FDA Approval of Moxetumomab Pasudotox in Hairy Cell Leukemia

Javier A. Pinilla-Ibarz, MD, PhD, senior member, Moffitt Cancer Center, discusses the FDA approval of moxetumomab pasudotox for the treatment of adult patients with hairy cell leukemia who have received at least 2 prior lines of therapy.

In a single-arm, open-label study of 80 patients with hairy cell leukemia, the CD22-directed recombinant immunotoxin moxetumomab pasudotox induced a complete remission lasting for over 180 days for 30% of patients, as well as an objective response rate of 75%.

The approval is for patients that have recieved at least 2 prior lines of therapy, including treatment with a purine nucleoside analog.