Junshi and Coherus’s Toripalimab Receive the US FDA’s Breakthrough Therapy Designation as 1L Treatment of Nasopharyngeal Carcinoma

August 13, 2021 Auto Bot Breakthrough Therapy Designation, Coherus, FDA, Junshi, regulatory, Toripalimab 0

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

Click here to­ read full press release/ article | Ref: Globe Newswire | Image: PR Newswire

The post Junshi and Coherus’s Toripalimab Receive the US FDA’s Breakthrough Therapy Designation as 1L Treatment of Nasopharyngeal Carcinoma first appeared on PharmaShots.