China-based Akeso Biopharma (HKG: 9926) has announced the submission of a supplementary New Drug Application (sNDA) for its innovative bispecific antibody, cadonilimab (AK104), which targets both programmed death-1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). The sNDA filing seeks to expand the use of cadonilimab in combination with chemotherapy and optionally bevacizumab as a first-line treatment for patients with persistent, recurrent, or metastatic cervical cancer. The China Center for Drug Evaluation (CDE) has accepted the filing for review.
Cadonilimab received conditional approval in China in June 2022 for the treatment of patients with recurrent or metastatic cervical cancer who had previously failed platinum-based chemotherapy. Akeso is also anticipating a regulatory decision in China for cadonilimab’s use as a first-line treatment for unresectable, locally advanced, recurrent, or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma in combination with chemotherapy.- Flcube.com
