FDA Grants Breakthrough Therapy Designation to Emi-Le for Adenoid Cystic Carcinoma

Emi-Le FDA Breakthrough Therapy Designation for ACCThe FDA granted breakthrough therapy designation to Emi-Le for the treatment of patients with locally advanced, recurrent, or metastatic ACC featuring solid histology or high-grade transformation.Phase 1 clinical trial data demonstrated that Emi-Le has a manageable safety profile and achieved a 55.6% ORR in evaluable patients with ACC-1.Emi-Le has previously earned FDA fast track designations for the treatment of patients with other aggressive cancers, specifically advanced or metastatic triple-negative and HER2-low or -negative breast cancers.