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Toripalimab FDA Approval Status

Last updated by Judith Stewart, BPharm on Sep 6, 2021.

FDA Approved: No
Generic name: toripalimab
Company: Coherus Biosciences, Inc.
Treatment for: Nasopharyngeal Carcinoma

Toripalimab is an anti-PD-1 monoclonal antibody in development for the treatment of nasopharyngeal carcinoma.

  • Toripalimab works to recharge the immune system’s ability to attack and kill tumor cells by blocking PD-1 interactions with the PD-L1 and PD-L2 ligands.
  • A Biologics License Application (BLA) has been submitted to FDA for toripalimab in combination with gemcitabine and cisplatin for first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma (NPC) and toripalimab monotherapy for second-line or above treatment of recurrent or metastatic NPC after platinum-containing chemotherapy.
  • The FDA has also granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and orphan drug designation for NPC, mucosal melanoma and soft tissue sarcoma.

Development timeline for toripalimab

DateArticle
May  2, 2022Coherus and Junshi Biosciences Receive Complete Response Letter from U.S. FDA for Toripalimab BLA
Sep  1, 2021Coherus and Junshi Biosciences Announce Completion of Rolling BLA Submission to U.S. FDA for Toripalimab for the Treatment of Nasopharyngeal Carcinoma
Aug 18, 2021Coherus and Junshi Biosciences Announce Positive Interim Results of CHOICE-01, a Phase 3 Clinical Trial Evaluating Toripalimab in Combination with Chemotherapy as First-Line Treatment for Non-Small Cell Lung Cancer
Aug 12, 2021Junshi Biosciences and Coherus Announce U.S. FDA Breakthrough Therapy Designation Granted for Toripalimab for 1st Line Treatment of Nasopharyngeal Carcinoma

Further information

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