USFDA grants Fast Track Designation to Zentalis Pharma ZN-c3 for Uterine Serous Carcinoma

"USC is a devastating endometrial cancer marked by low survival rates and high rates of recurrence. Receiving Fast Track designation for ZN-c3 is an important milestone, as it underscores the need for novel, effective treatment options for this aggressive and often fatal disease," commented Dr. Anthony Sun, Chairman and Chief Executive Officer of Zentalis. "ZN-c3, our potentially first- and best-in-class oral WEE1 inhibitor, is a notable clinical advancement in DNA damage response and synthetic lethality and is currently being evaluated in a potentially registrational Phase 2 trial in USC. We are grateful for the opportunity to have more frequent interactions with the FDA as we continue to quickly advance the development of this promising candidate for patients in need."

Fast Track designation aims to facilitate the development and accelerate the review of new therapeutics that are intended to treat serious or life-threatening conditions and that potentially address an unmet medical need. Drugs that are granted this designation are given the opportunity for more frequent interactions with the FDA, as well as potential pathways for expedited approval.