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# FDA Grants Fast Track Status to Trethera’s Lung Cancer Drug
- URL: https://www.fdaweb.com/fda-grants-fast-track-status-to-tretheras-lung-cancer-drug/
- Published: 2026-10-02T17:50:09.000Z
- Updated: 2026-10-02T17:50:09.000Z
- Author: David McFarland
- Tags: Drugs

The FDA has granted fast track status to Trethera’s TRE-515 in combination with KRAS inhibitors for certain patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC). The designation covers TRE-515 combined with KRAS inhibitors for patients with G12C mutation-positive NSCLC previously treated with an anti-PD-(L)1 antibody and platinum-based chemotherapy, according to the company.

TRE-515 is described as an oral, first-in-class investigational inhibitor of deoxycytidine kinase (dCK), an enzyme in the nucleoside salvage pathway. Trethera is evaluating whether blocking the pathway can counter a metabolic mechanism cancer cells may use to survive targeted therapies.

“KRAS G12C inhibitors have transformed the NSCLC treatment landscape, but resistance and incomplete responses remain major challenges,” Trethera chairman and CEO **Ken Schultz** said. “We believe TRE-515 has the potential to address a key metabolic escape pathway used by cancer cells.”

Trethera said preclinical studies found that tumors treated with KRAS inhibitors continued to exhibit dCK activity, while treatment with TRE-515 blocked that activity. It noted that TRE-515 also has shown favorable safety and antitumor activity in an ongoing first-in-human study.