Novel Adenoid Cystic Carcinoma Drug Earns FDA Breakthrough Therapy Status
The FDA has granted breakthrough therapy designation to emiltatug ledadotin (Emi‑Le) for patients with adenoid cystic carcinoma (ACC).
The FDA has granted Breakthrough Therapy designation to emiltatug ledadotin (Emi‑Le), an anti‑B7‑H4 antibody‑drug conjugate, for the treatment of adenoid cystic carcinoma (ACC). The designation applies to locally advanced, recurrent or metastatic ACC with solid histology or high‑grade transformation. A multicenter phase 1 trial (NCT05377996) is evaluating Emi‑Le monotherapy via intravenous infusion in patients with aggressive ACC, breast cancer, endometrial cancer and ovarian cancer. Preliminary data indicate that Emi‑Le was well tolerated and produced confirmed objective responses across these tumor types.
ACC is a rare malignancy with limited systemic therapy options; a breakthrough designation may accelerate development of a potentially effective treatment.
Bizonyítékszint: Korai humán adat. Kis vagy feltáró emberi adat.
Kapcsolódó jelek
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- Adenoid cystic carcinoma (ACC)
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