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Zentalis Pharma Says FDA Grants Fast Track Status on Azenosertib Cancer Drug Candidate
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Zentalis Pharma Says FDA Grants Fast Track Status on Azenosertib Cancer Drug Candidate
Jan 9, 2025 10:12 AM

12:40 PM EST, 01/09/2025 (MT Newswires) -- 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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