Ellipses’ selective RET inhibitor granted Fast Track designation by FDA

UK-based Ellipses Pharma has received Fast Track designation from the US Food and Drug Administration (FDA) for its selective RET inhibitor EP0031/A400 for the potential treatment of RET-fusion positive non-small cell lung cancer (NSCLC).

Data from an ongoing modular interventional Phase I/II trial, which aims to assess the safety, side effects and effectiveness of EP0031/A400 in advanced RET-altered malignancies, were submitted in support of the application.

"Confirms the potential for EP0031/A400 to address real unmet need"Patients treated with the compound showed tumor responses in NSCLC patients who were previously treated with first-generation SRIs.