Servier announced that the FDA has granted breakthrough therapy designation to emiltatug ledadotin (Emi-Le), an investigational antibody drug conjugate directed against B7-H4, for the treatment of patients with locally advanced, recurrent or metastatic adenoid cystic carcinoma with solid histology or high-grade transformation. ACC is a challenging rare cancer usually arising within the salivary gland with no currently approved treatments for advanced or metastatic disease.
Emi-Le is a potentially innovative and differentiated ADC directed against B7-H4, a well-characterized target in certain cancers including ACC. The therapy is currently under clinical development in the U.S. for potential use in aggressive ACC and other cancers.
"At Servier, we are committed to pursuing first-in-class medicines for rare diseases in oncology," said Peter Adamson, Global Head, Oncology Clinical Development, Servier. "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."
Emi-Le is being evaluated in a multicenter Phase 1 trial investigating 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.
The designation follows Servier's recent acquisition of Day One Biopharmaceuticals. "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," Adamson said.
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