After two deaths, FDA hits the brakes on leukemia treatment study

Feb. 20, 2019

The FDA has placed a partial hold on a phase 1 study into the study of a treatment for acute myeloid leukemia (AML).

The study is being led by Xencor, a clinical-stage biopharma company specializing in monoclonal antibodies that target cancer, autoimmune disease, allergic diseases and asthma. For this study, Xencor is developing a treatment known as XmAb14045, a CD123 and CD3 bispecific antibody designed for patients with relapsed or refractory AML and other CD123-expressing hematologic malignancies.

One of the patient deaths reportedly occurred after the first dose of XmAb14045, which triggered cytokine release syndrome. The other patient developed acute pulmonary edema after several doses of the treatment.

The FDA said that patients experiencing clinical benefit from the treatment can continue with the trial for now, but that no new patients can be entered into the study. 

Novartis partnered with Xencor for the XmAb14045 study and shares costs for the development of the treatment.

Read the full report.