MorphoSys AG announced that their investigational drug, tulmimetostat, a next-generation dual inhibitor of EZH2 and EZH1, has received the FDA’s Fast Track status. This designation is for treating patients with advanced, recurrent, or metastatic endometrial cancer with ARID1A mutations who haven’t responded to at least one previous treatment.
Tulmimetostat has been designed to outperform the first-generation EZH2 inhibitors by offering higher potency, longer target residence time, and extended half-life, which could result in better anti-cancer effects. The Fast Track status in endometrial cancer was awarded based on preclinical data from an ongoing Phase 1/2 trial and laboratory results. This trial explores tulmimetostat’s solo efficacy in treating various advanced tumors and lymphomas, including ARID1A-mutated endometrial and ovarian cancers, among others.
Tim Demuth, M.D., the Chief Research and Development Officer at MorphoSys, highlighted the significance of the FDA’s Fast Track designation for tulmimetostat in treating ARID1A-mutated endometrial cancer. He emphasized the investigational therapy’s potential for a patient group with scarce treatment choices. Demuth further mentioned that the initial results from the Phase 1/2 study of tulmimetostat appear encouraging.
Source: MorphoSys Receives U.S. FDA Fast Track Designation for Tulmimetostat in Endometrial Cancer.
https://www.morphosys.com/en/news/morphosys-receives-us-fda-fast-track-designation-tulmimetostat-endometrial-cancer
