Junshi Biosciences Reports the NMPA Acceptance of sNDA of Toripalimab for Advanced Triple-Negative Breast Cancer
Shots:
- 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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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.
