Zentalis Pharmaceuticals (ZNTL) said Thursday the US Food and Drug Administration granted fast track designation to the company's azenosertib drug candidate to treat several forms of platinum-resistant gynecological cancers in patients.
Fast track designation by the US Food and Drug Administration is intended to support and accelerate development of medicines and therapies showing a strong potential to treat serious medical conditions often lacking effective treatments at this time, the company said.
The FDA temporarily placed a partial hold on clinical testing of azenosertib as a monotherapy for ovarian, fallopian tube or primary peritoneal cancers in June 2024 following the death of two trial participants due to suspected blood-related infections. The agency lifted its hold on Sept. 16.
Zentalis also said Thursday it will present top-line data from those studies as well as another trial of azenosertib in combination with Pfizer's (PFE) encorafenib and Eli Lilly's (LLY) cetuximab chemotherapies in patients with metastatic colorectal cancer.
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