Preliminary analysis of the interim data from the Phase 2 portion of our ONC-002 trial supported our belief that REQORSA® may provide medical benefit in several subpopulations of NSCLC patients for which there is an unmet medical need, and may provide pathways for accelerated approval by the U.S. Food and Drug Administration, or FDA. Data from our clinical trials, along with our preclinical data, provided the basis for our application for a Fast Track Designation, which was granted by FDA on January 14, 2020. 

In granting our Fast Track Designation, the FDA found that REQORSA may provide a benefit over existing therapies for patients whose tumors progress on AstraZeneca’s Tagrisso. The FDA Fast Track Designation is for use of REQORSA in combination with TKI Tagrisso for the treatment of NSCLC patients with EGFR mutations whose tumors progressed after treatment with Tagrisso. We believe that the Fast Track Designation provides a clearly defined pathway toward FDA approval of the combination of REQORSA with Tagrisso.

We initiated the Acclaim-1 clinical trial in June 2021, a Phase 1/2 clinical trial of REQORSA combined with Tagrisso. To learn more about Acclaim-1, please visit ClinicalTrials.gov.

To learn more about scientific evidence and studies supporting REQORSA and the TUSC2 gene, please refer to our TUSC2 Bibliography page.

Tagrisso® is a registered trademark of AstraZeneca.

Tarceva® is a registered trademark of Astellas and the Roche Group of companies.