Servier recently announced that the US 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, 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.

Peter Adamson, Global Head, Oncology Clinical Development, Servier, said, "At Servier, we are committed to pursuing first-in-class medicines for rare diseases in oncology. This breakthrough therapy designation for Emi-Le will help accelerate development and may provide an important new treatment option for patients with few effective choices today. Following the acquisition of Day One Biopharmaceuticals, this designation reinforces our confidence in Day One's portfolio and our commitment to advancing innovative treatments for patients facing difficult-to-treat cancers."

Emi-Le is being evaluated in a multicenter phase 1 trial to investigate the safety, tolerability and anti-tumor activity of the treatment in patients with solid tumors, 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 tumor types.