Home » FDA Allows Patient Enrollment to Resume in Curis Leukemia and Lymphoma Trials
FDA Allows Patient Enrollment to Resume in Curis Leukemia and Lymphoma Trials
September 2, 2022
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.
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