Zentalis Gets FDA Fast-Track Designation for Azenosertib

Dow Jones

2025/01/09

By Colin Kellaher

Zentalis Pharmaceuticals has won a U.S. Food and Drug Administration fast-track designation for its lead product candidate azenosertib for certain cancer patients with high levels of the Cyclin E1 protein.

The San Diego clinical-stage biopharmaceutical company on Thursday said the designation covers azenosertib for the treatment of patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer who are positive via Cyclin E1 immunohistochemistry for protein levels.

The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.

Zentalis said Cyclin E1-positive ovarian cancer has historically been associated with resistance to chemotherapy and poor patient outcomes.

The company is currently evaluating azenosertib as a monotherapy and in combination with clinical studies in ovarian cancer and other tumor types.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

January 09, 2025 07:21 ET (12:21 GMT)

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