FDA grants breakthrough therapy designation to Emi-Le for advanced adenoid cystic carcinoma

The U.S. Food and Drug Administration has granted breakthrough therapy designation to Emi-Le for patients with locally advanced, recurrent or metastatic adenoid cystic carcinoma (ACC).

Phase 1 trial results showed a manageable safety profile and an objective response rate of 55.6% among evaluable ACC patients.

Emi-Le previously received FDA fast track designations for treating aggressive breast cancers, including advanced triple-negative and HER2-low or negative disease.