Leukogene Therapeutics gains FDA ODD status for M2T-CD33
The designation highlights the considerable unmet medical needs of patients with AML and recognises LTI-214’s therapeutic potential as a new treatment for this aggressive form of blood cancer.
The US Food and Drug Administration (FDA) has approved two of Merck & Co’s (MSD) Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), each combined with Padcev (enfortumab vedotin-ejfv), for adults with muscle-invasive bladder cancer (MIBC).