Coherus and Junshi’s Toripalimab Receive the US FDA’s Orphan Drug Designation for the Treatment of Esophageal Cancer

November 16, 2021 Auto Bot Coherus, Esophageal Cancer, FDA, Junshi, Orphan Drug Designation, regulatory, Toripalimab 0

Shots:

  • The designation is based on the results of the P-III JUPITER-06 clinical trial that evaluates toripalimab + CT vs CT alone in patients with advanced or metastatic ESCC
  • The study met the co-primary EPs i.e., improvements in PFS & OS for patients treated with the toripalimab + CT compared to CT alone
  • The company plans to submit sBLA to the US FDA for toripalimab in combination with Pt-based CT as a 1L treatment of advanced or metastatic ESCC in 2022. Additionally, toripalimab’s BLA is currently under the US FDA’s priority review for advanced recurrent or metastatic nasopharyngeal carcinoma with an anticipated PDUFA date is Apr 2022

Click here to­ read the full press release/ article | Ref: Globe Newswire | Image: Globe Newswire

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