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# FDA Delays Toripalimab PDUFA Action Date
- URL: https://www.fdaweb.com/fda-delays-toripalimab-pdufa-action-date/
- Published: 2023-01-06T12:00:00.000Z
- Updated: 2026-09-14T18:10:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153439

FDA has delayed the 12/23/22 PDUFA action date for the Junshi Biosciences and Coherus BLA for toripalimab to treat recurrent or metastatic nasopharyngeal carcinoma (NPC). The companies [say](https://www.globenewswire.com/news-release/2022/12/25/2579403/0/en/Junshi-Biosciences-and-Coherus-Share-Update-on-the-FDA-Review-of-the-Biologics-License-Application-BLA-for-Toripalimab-as-Treatment-for-Recurrent-or-Metastatic-Nasopharyngeal-Carci.html?ref=fdaweb.com) FDA previously communicated that an on-site inspection of the Junshi Biosciences manufacturing facility for toripalimab is required before the BLA can be approved. The agency indicated it could not inspect during the current review cycle due to the impact of Covid-19 travel restrictions involving China. The companies say they are in discussions with FDA about the pre-approval inspection.

Toripalimab is described as an anti-PD-1 monoclonal antibody that blocks PD-L1 binding to the PD-1 receptor at a unique site that minimizes opportunities for the tumor cell to evade the immune system and decreases PD-1’s expression on the T-cell as a second method of restoring the body’s immune response.

FDA has granted priority review for the BLA for use in combination with gemcitabine and cisplatin as first-line treatment for patients with advanced recurrent or metastatic NPC and as monotherapy for the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy. The agency also granted breakthrough therapy for second- or third-line treatment of metastatic NPC. And it has given toripalimab fast track designation to treat mucosal melanoma and orphan drug designation to treat NPC, mucosal melanoma, soft tissue sarcoma, and small cell lung cancer.