China’s NMPA accepted the NDA for opamtistomig (LBL-024), a PD-L1/4-1BB–directed bispecific antibody, for patients with previously treated advanced extrapulmonary neuroendocrine carcinoma (EP-NEC). The agency granted priority review, with CDE fast-tracking the application after completion of enrollment in a registrational study. Opamtistomig is designed to combine PD-L1 blockade with conditional 4-1BB agonism aimed at reactivating exhausted T cells, including in immunologically “cold” tumor settings with limited options. The filing is positioned as potentially the first 4-1BB–targeting bispecific—and first approved agonistic antibody—if regulators approve it.
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