Shanghai Junshi Reports the TGA’s Acceptance for Toripalimab in the Treatment of Nasopharyngeal Carcinoma
Shots:
- Shanghai Junshi announces the acceptance of TGA for its NCE application for toripalimab+ cisplatin & gemcitabine as 1L treatment of metastatic or recurrent locally advanced NPC & as monotx. for recurrent, unresectable, or metastatic NPC
- The application was supported by P-III (JUPITER-02) study results which depicted improved PFS & OS with 48% of disease progression & P-II (POLARIS-02) study the result that showed ORR of 20.5%, mDoR of 12.8mos. & median OS of 17.4mos.
- Toripalimab, an anti-PD-1 mAb is approved for 6 indications in China, with 4 sNDAs awaiting review. In the US, it's approved for 2 NPC indications, while marketing approval applications for NPC & esophageal carcinoma are under review in the EU & UK
Ref: Yahoo Finance | Image: Jushi Biosciences
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Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
