Emiltatug Ledadotin has been granted Breakthrough Therapy Designation by the U.S. FDA for the treatment of Adenoid cystic carcinoma

CAR-T Digest - August 2020

12 May 2026: Emiltatug Ledadotin has been granted Breakthrough Therapy Designation by the U.S. FDA for the treatment of Adenoid cystic carcinoma

Servier has secured U.S. FDA Breakthrough Therapy Designation for Emiltatug Ledadotin (Emi-Le), its B7-H4-targeted ADC, for the treatment of patients with locally advanced, recurrent, or metastatic adenoid cystic carcinoma (ACC), a rare and difficult-to-treat salivary gland cancer with no approved therapies in the advanced setting
The designation highlights growing interest in B7-H4 as an emerging ADC target, particularly in tumors with limited treatment options, while also reinforcing Servier’s strategy to expand into first-in-class oncology therapies following its acquisition of Day One Biopharmaceuticals
Emi-Le is designed with a target-optimized DAR 6 configuration and a proprietary auristatin-F payload intended to balance potent antitumor activity with a controlled bystander effect, potentially supporting both efficacy and tolerability across solid tumors
Early Phase 1 data showed manageable safety findings along with confirmed objective responses across multiple tumor types, including ACC, breast, endometrial, and ovarian cancers, supporting continued development of the ADC in both rare and broader oncology indications
Alongside this latest Breakthrough Therapy Designation in ACC, Emi-Le has also received prior FDA FTD in advanced breast cancer settings, positioning the B7-H4 ADC as a potentially differentiated next-generation oncology asset within Servier’s pipeline