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

November 2, 2021 Auto Bot BLA, Coherus, FDA, Junshi, regulatory, Toripalimab 0

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

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