FDA Grants Fast Track Designation to ZL-1310 in Extensive Stage SCLC
The FDA granted fast track designation to ZL-1310, a potential first‑in‑class DLL3‑targeted antibody‑drug conjugate (ADC), to treat patients with extensive‑stage small cell lung cancer (ES‑SCLC).
The FDA granted fast track designation to ZL-1310, a DLL3‑targeted antibody‑drug conjugate (ADC), to treat patients with extensive‑stage small cell lung cancer (ES‑SCLC). A global phase 1 trial (NCT06179069) is evaluating monotherapy and combination with atezolizumab; interim data reveal early antitumor activity and a 74% overall response rate in 19 evaluable patients.
Fast‑track designation is a significant regulatory milestone that can expedite the development and availability of a promising therapy for patients with limited treatment options for extensive‑stage small cell lung cancer.
Evidence level: Korai humán adat. Kis vagy feltáró emberi adat.
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