Junshi and Coherus Report the US FDA Acceptance of BLA for Toripalimab to Treat Nasopharyngeal Carcinoma

Shots:

• The US FDA has accepted the BLA for toripalimab + CT (gemcitabine & cisplatin) & toripalimab as monothx. to treat advanced recurrent or metastatic NPC after platinum-containing CT. The US FDA has granted PR designation of toripalimab’ BLA with an anticipated PDUFA date on Apr’22
• The BLA is based on the P-II POLARIS-02 & P-III JUPITER-02 study. In 2021, Coherus got the licensed rights to develop and commercialize toripalimab in the US and Canada
• In Aug’21, toripalimab + CT has received the BTD for recurrent, LA, or primary metastatic non-keratinizing NPC. Additionally, both companies plan to file additional toripalimab’s BLA with the US FDA over the next 3yrs.  for multiple cancer

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