FDA Allows Patient Enrollment to Resume in Curis Leukemia and Lymphoma Trials

The FDA has partially lifted a clinical hold it placed in April on Curis’ leukemia trial of emavusertib as a monotherapy, allowing patient enrollment to resume.

The FDA also lifted a partial hold it placed on the company’s phase 1/2 clinical trial investigating emavusertib in lymphoma.

Both partial clinical holds were imposed after a patient death in the leukemia study. The patient experienced rhabdomyolysis, a condition is which damaged muscle tissue releases proteins and electrolytes into the blood. The condition was previously identified as a dose-limiting toxicity of emavusertib.

A partial hold remains in place for the combination therapy phase 1b and an expansion phase 2a of the leukemia trial.