Junshi Biosciences Reports the NMPA Acceptance of sNDA of Toripalimab for Advanced Triple-Negative Breast Cancer
- The NMPA has accepted the sNDA for toripalimab + albumin-bound paclitaxel to treat PD-L1+ (CPS ≥1) untreated metastatic or recurrent metastatic TNBC
- The sNDA was based on the P-III study (TORCHLIGHT) evaluating toripalimab + albumin-bound paclitaxel vs PBO + albumin-bound paclitaxel in 531 patients across 56 centers which showed prolonged PFS of PD-L1+ patients & OS showed a clear trend of improvement in PD-1+ patients & in all patients regardless of PD-1 status
- The safety profile was consistent with known checkpoint inhibitor-related risks with no new safety signals. The BLA for toripalimab + gemcitabine/cisplatin as 1L treatment of advanced recurrent or metastatic NPC & toripalimab monotx. for 2L or later treatment of recurrent or metastatic NPC is under the US FDA’s review
Ref: Globenewswire | Image: Junshi Biosciences
Related News:- Junshi Biosciences Collaborated with Dr. Reddy’s to Develop and Commercialize Toripalimab for the Treatment of Cancer
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