11 Apr 2023: Toripalimab / NSCLC / Junshi Biosciences: Accepted Supplemental New Drug Application in China
The NMPA had formally accepted the NDA submitted by Junshi Biosciences for Toripalimab in combination with Chemo as a perioperative treatment and Toripalimab monotherapy as a consolidation therapy after adjuvant therapy to treat Stage 3 NSCLC
This NDA was based on Phase 3 Neotorch study. The recent outcomes demonstrated that using an anti-PD-1 monoclonal antibody in the preoperative period can significantly extend the Event Free Survival (EFS) of patients suffering from NSCLC
The comprehensive data will be disclosed internationally for the first time in an oral presentation at the ASCO Plenary Series on April 20, 2023
“This newly applied indication for operable NSCLC patients will open the door to the clinical application of toripalimab in the early stages of the disease,” said Dr. Jianjun ZOU, President of Global Research and Development at Junshi Biosciences
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