FDA Lifts Partial Clinical Hold on the TakeAim Lymphoma Phase I/II Study

The U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the TakeAim Lymphoma phase I/II study of emavusertib after reviewing the comprehensive data package submitted by the drug’s manufacturer.

The partial clinical hold was lifted following an agreement on strategy between the manufacturer of the drug and the FDA for the identification and management of rhabdomyolysis, as well as on the enrollment of at least nine additional patients at the emavusertib 200 mg dose level in combination with ibrutinib.

The FDA had placed separate partial clinical holds on the TakeAim Leukemia and TakeAim Lymphoma studies on April 4 and April 11, 2022, respectively. The partial hold on the TakeAim Leukemia study was issued by the FDA Division of Hematologic Malignancies 1. The partial hold on the TakeAim Lymphoma study and the lifting of that hold were issued by the FDA Division of Hematologic Malignancies 2.

Source: Business Wire, August 2022