The Food and Drug Administration (FDA) has granted Fast Track designation to ZN-c3, an investigational oral WEE1 inhibitor, for the treatment of recurrent or persistent uterine serous carcinoma in adult women.
Uterine serous carcinoma is an aggressive type of endometrial cancer, which accounts for less than 10% of all endometrial cancers and 80% of endometrial cancer-related deaths. ZN-c3 is a potential first-in-class inhibitor of WEE1, a DNA damage response protein, designed to generate sufficient DNA damage in cancer cells causing cell death. The Company believes that ZN-c3 will prevent tumor growth and lead to tumor regression.
The efficacy and safety of ZN-c3 is currently being evaluated in adult women with recurrent or persistent uterine serous carcinoma in an ongoing open-label, multicenter phase 2 study (ClinicalTrials.gov Identifier: NCT04814108).
The FDA’s Fast Track process allows for expedited review of drugs that are expected to fill an unmet need such as providing a therapy that may be better than currently available treatments.
“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 CEO of Zentalis.
Zentalis Pharmaceuticals announces Fast Track designation granted by the US FDA to ZN-c3 for the treatment of uterine serous carcinoma. News release. Zentalis Pharmaceuticals, Inc. Accessed November 17, 2021. https://ir.zentalis.com/news-releases/news-release-details/zentalis-pharmaceuticals-announces-fast-track-designation.