Servier, a France-based pharmaceutical company, announced on Tuesday that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to Emi-Le, an investigational ADC directed against B7-H4, a well-characterised target in certain cancers.

One of those cancers, adenoid cystic carcinoma (ACC), is a challenging rare cancer usually arising within the salivary gland with no currently approved treatments for advanced or metastatic disease. The breakthrough therapy designation has been granted for treatment of patients with locally advanced, recurrent or metastatic ACC with solid histology or high-grade transformation.

Emi-Le is being evaluated in a multicentre Phase 1 trial to investigate the safety, tolerability and anti-tumour activity of the treatment in patients with solid tumours, including aggressive ACC, breast, endometrial and ovarian cancers. In the initial data reported from Phase 1, Emi-Le had manageable side effects, and confirmed objective responses were observed across multiple tumour types.