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
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