Becotatug Vedotin: First EGFR-Targeted ADC Approved in China for Recurrent or Metastatic Nasopharyngeal Carcinoma

Rákkutatás · Nasopharyngeal carcinoma · EGFR

In October 2025, becotatug vedotin (Meiyouheng®), developed by Lepu Biopharma, received marketing approval from the National Medical Products Administration (NMPA) in China for the treatment of recurrent or metastatic nasopharyngeal carcinoma (R/M NPC) in adults who have failed at least two lines of systemic chemotherapy and PD‑1/PD‑L1 inhibitor therapy.

Becotatug vedotin (Meiyouheng®) is an EGFR‑targeted antibody‑drug conjugate (ADC) that received marketing approval from China’s National Medical Products Administration (NMPA) on 10 October 2025 for the treatment of recurrent or metastatic nasopharyngeal carcinoma (R/M NPC) in adults who had received at least two prior lines of systemic chemotherapy plus PD‑1/PD‑L1 inhibitor therapy. In phase II studies, the drug demonstrated clinically meaningful activity (ORR 42 % (95 % CI 30–56), DCR 81 % (95 % CI 69–90), median PFS 5.8 months, median OS 15.8 months) and a manageable safety profile (grade ≥ 3 TRAEs in 39 % of patients). The approval marks the first EGFR‑targeted ADC for R/M NPC in China and paves the way for further investigations in other EGFR‑positive solid tumours and combination regimens.

This is the first EGFR‑targeted antibody‑drug conjugate approved for treating recurrent or metastatic nasopharyngeal carcinoma in China, offering a new therapeutic option for patients who have exhausted standard platinum‑based chemotherapy and immune‑checkpoint blockade.

Bizonyítékszint: Sejtvonalas. Laboratóriumi sejtekben vizsgálták.

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