Junshi and Coherus's Toripalimab Receive the US FDA's Breakthrough Therapy Designation as 1L Treatment of Nasopharyngeal Carcinoma
Shots:
- The designation is based on the P-III JUPITER-02 trial evaluating toripalimab + CT vs CT alone in patients with NPC. The result was presented at ASCO 2021
- The results demonstrated an improvement in PFS. The trial also meets 2EPs of PFS assessed by the investigator and ORR as assessed by BIRC including higher DoR; DCR & OS rates while safety profile is consistent with that observed in previously reported clinical trials
- The BLA submission is expected to complete in Q3’21 for toripalimab + CT as 1L NPC and for toripalimab monothx. as 1L & 2L NPC. The therapy has received FTD for the treatment of mucosal melanoma and ODD for NPC- mucosal melanoma- and soft tissue sarcoma
| Ref: Globe Newswire | Image: PR Newswire
Click here to read the full press release
Tags
This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com