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Junshi Reports MAA Submission of Toripalimab to the EMA for Nasopharyngeal Carcinoma and Esophageal Squamous Cell Carcinoma

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Junshi Reports MAA Submission of Toripalimab to the EMA for Nasopharyngeal Carcinoma and Esophageal Squamous Cell Carcinoma

Shots:

  • The company has submitted the MAA to the EMA for toripalimab to treat NPC in combination with cisplatin and gemcitabine & for ESCC in combination with paclitaxel and cisplatin
  • The MAA was based on the P-III (JUPITER-02) trial published in Nature Medicine and P-II (POLARIS-02) published in the Journal of Clinical Oncology for toripalimab in 289 & 401 patients with NPC. The BLA resubmission of toripalimab is under the US FDA’s review with an expected PDUFA action date is Dec 23, 2022
  • The MAA was also based on the P-III (JUPITER-06) trial to evaluate toripalimab + CT vs PBO + CT in 514 patients with ESCC, published in Cancer Cell. The therapy has also received the ODD from the US FDA for the same indication

Ref: Globenewswire  | Image: Junshi

Click here to­ read the full press release 

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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