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Zentalis Pharmaceuticals Announces Fast Track Designation Granted by the U.S. FDA to ZN-c3 for the Treatment of Uterine Serous Carcinoma
Potentially registrational Phase 2 trial of ZN-c3 in USC is underway, with initial enrollment and safety update expected in 2H 2022 NEW YORK and SAN DIEGO,
About this update from Zentalis Pharmaceuticals, Inc.
[{"type":"text","content":"Potentially registrational Phase 2 trial of ZN-c3 in USC is underway, with initial enrollment and safety update expected in 2H 2022\nNEW YORK and SAN DIEGO, Nov. 17, 2021 (GLOBE NEWSWIRE) -- Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ZN-c3, the Company’s oral WEE1 inhibitor product candidate, for the treatment of recurrent or persistent uterine serous carcinoma (USC) in adult women. “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. About Uterine Serous Carcinoma Uterine serous carcinoma is an aggressive variant of endometrial cancer that accounts for less than 10% of all endometrial cancers, yet 80% of endometrial cancer–related deaths. In the U.S., ~6,500 women are diagnosed annually, with ~70% presenting with Stage III or IV disease at diagnosis. Currently, the standard of care for treating USC is staging surgery together with chemotherapy or radiotherapy; yet, the recurrence rates post-surgery are extremely high and result in low patient survival rates. There rema...