On May 12, 2026 Servier reported 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-characterized 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.
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"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," said Peter Adamson, Global Head, Oncology Clinical Development, Servier. "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.
About Emi-Le
Emi-Le is a B7-H4-directed Dolasynthen ADC with a precise, target-optimized drug-to-antibody ratio (DAR 6) and a proprietary auristatin-F HPA payload with controlled bystander effect. This candidate is under evaluation in an ongoing Phase 1 clinical trial (previously with Mersana Therapeutics). The U.S. Food and Drug Administration has granted Fast Track designations to Emi-Le for the treatment of 1) adult patients with advanced or metastatic triple-negative breast cancer, and 2) advanced or metastatic HER2 low / HER2 negative breast cancer post-topo-1 ADC (including TNBC and certain HR+ breast cancers). It has also received Breakthrough Designation from the FDA for the treatment of patients with locally advanced, recurrent or metastatic adenoid cystic carcinoma with solid histology or high-grade transformation. For more information about the trial, visit clinicaltrials.gov (NCT05377996).
About Adenoid Cystic Carcinoma
Adenoid cystic carcinoma (ACC) occurs in the secretory glands, typically in the head and neck, but also in other areas of the body. Globally, more than 200,000 people have ACC. It is diagnosed in roughly four per one million people annually, and does not discriminate by ethnicity or lifestyle factors. Today there are no approved or preferred systemic therapies to treat advanced or metastatic ACC; most people are treated with surgery or radiation, but the disease recurs in 50 percent of cases, often becoming more aggressive with metastases in distant areas of the body.
(Press release, Servier, MAY 12, 2026, View Source [SID1234665570])