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# Trethera Gets Fast Track for Prostate Cancer Drug
- URL: https://www.fdaweb.com/trethera-gets-fast-track-for-prostate-cancer-drug/
- Published: 2025-07-09T12:00:00.000Z
- Updated: 2026-09-14T15:16:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159480

FDA has granted Trethera a fast track designation for TRE-515 for treating prostate cancer. TRE-515 is currently in Phase 1 clinical trials for solid tumors. It is described by the company as a first-in-class clinical-stage drug that inhibits deoxycytidine kinase, a rate-limiting enzyme in the nucleoside salvage pathway, one of two biosynthetic pathways that generate DNA precursors. “It is believed that some forms of cancer may be preferentially dependent on the salvage pathway to support tumor growth, and certain autoimmune diseases might also respond to TRE-515 treatment,” the company says.

The designation applies to TRE-515 in combination with radioligand therapy for treating prostate-specific membrane antigen (PSMA)-positive metastatic castration resistant prostate cancer, a condition impacting thousands of patients. PSMA, an important disease biomarker, is detected in over 80% of prostate cancer cases, enabling earlier identification and intervention, according to the company.

The designation was supported by data from Trethera’s first-in-human Phase 1 trial in cancer patients as well as preclinical data, including findings presented at the recent American Association for Cancer Research annual meeting, according to Trethera. The ongoing multicenter Phase 1 dose-escalation study is evaluating TRE-515 as an oral monotherapy in adults with advanced solid tumors, assessing safety, tolerability, pharmacokinetics, and preliminary efficacy, it says. TRE-515 reportedly has demonstrated early signs of antitumor activity with a favorable safety profile, including an 18-fold dose escalation without limiting toxicities.