Fast Track Status for Zenith NUT Cancer Drug

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.