Elevation Oncology, Inc. announced on September 23, 2024, that the U.S. Food and Drug Administration (FDA) granted Fast Track designation (FTD) to EO-3021. This designation is for the treatment of adult patients with advanced or metastatic gastric or gastroesophageal junction (GC/GEJ) cancer expressing Claudin 18.2 that has progressed on or after prior therapy.
The FTD was based on nonclinical and initial clinical data from the ongoing Phase 1 trial of EO-3021. Early results showed a confirmed objective response rate of 42.8% in a Claudin 18.2-enriched subset of gastric and GEJ cancer, alongside a differentiated tolerability profile with minimal MMAE-associated toxicities.
Fast Track designation is designed to facilitate the development and expedite the review of therapeutic candidates for serious or life-threatening conditions. This allows for more frequent interactions with the FDA and potential eligibility for priority review and accelerated approval, which could significantly shorten the time to market for EO-3021.
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