The US FDA placed a partial clinical hold on the TakeAim leukemia & lymphoma study on Apr’22 which has now been lifted after the review of the comprehensive data package submitted by the company to the US FDA
The company will now resume patient enrolment of additional patients (n=6) in the P-Ia (TakeAim) leukemia study evaluating Emavusertib (200mg), an IRAK4 kinase inhibitor. The partial hold still remains intact on the P-Ib & expansion P-IIa study until the completion of the P-Ia study & approval by the US FDA to proceed to the next phase
The US FDA reviewed the additional data based on the risk of rhabdomyolysis provided by Curis along with its strategy to utilize objective laboratory measurements to identify rhabdomyolysis
Ref: PR Newswire | Image: Curis
