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
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