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# Fast Track Status for Zenith NUT Cancer Drug
- URL: https://www.fdaweb.com/fast-track-status-for-zenith-nut-cancer-drug/
- Published: 2025-07-16T12:00:00.000Z
- Updated: 2026-09-14T15:16:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159517

FDA has granted Zenith Epigenetics a fast-track designation for its ZEN-3694 and its use for treating metastatic or unresectable NUT carcinoma in patients who have previously received chemotherapy. NUT carcinoma is a rare but underdiagnosed cancer that typically affects the midline structures of the body, including the head, neck, and chest, according to the company.

ZEN-3694 is described by Zenith as a selective, oral BET (bromodomain and extra-terminal domain) inhibitor designed to disrupt the activity of cancer-promoting NUT fusion proteins. It says the drug is being studied in two ongoing clinical trials for NUT carcinoma — one in combination with abemaciclib and the other with cisplatin and etoposide. Preliminary results suggest that combining ZEN-3694 with abemaciclib leads to better response rates and longer duration of response than BET inhibitors alone.