Toripalimab filed with EU for oesophageal squamous cell carcinoma
Shanghai Junshi Biosciences has submitted a marketing authorization application to the European Medicines Agency for toripalimab
The indication requested in the MAA is for toripalimab combined with paclitaxel and cisplatin for the first-line treatment of patients with unresectable locally advanced/recurrent or metastatic oesophageal squamous cell carcinoma.
The MAA submission for ESCC is based on the results from JUPITER-06 (a randomized, placebo-controlled, double-blinded, multi-center Phase III trial, NCT03829969). The study results were first presented in a mini-oral session during the European Society for Medical Oncology Congress 2021, and later published in Cancer Cell with an editorial preview.
In May 2022, the supplemental new drug application for toripalimab in combination with paclitaxel and cisplatin for the first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic ESCC was approved by the NMPA in China. Additionally, US FDA has also granted an orphan drug designation to toripalimab for the treatment of patients with ESCC.
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