FDA Accepts BLA for Toripalimab for the Treatment of Nasopharyngeal Carcinoma

The FDA also granted Priority Review designation for the toripalimab BLA and set a Prescription Drug User Fee Act action date for April 2022; however, the FDA is not currently planning to hold an advisory committee meeting to discuss the application.

The FDA has accepted a Biologics License Application (BLA) for toripalimab in combination with gemcitabine and cisplatin for the 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, according to a Coherus press release.

Toripalimab is an anti-programmed cell death protein 1 (PD-1) monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, programmed death-ligand 1 (PD-L1) and PD-L2, and for enhanced receptor internalization, or endocytosis function.

The FDA also granted Priority Review designation for the toripalimab BLA and set a Prescription Drug User Fee Act action date for April 2022; however, the FDA is not currently planning to hold an advisory committee meeting to discuss the application.

“Nasopharyngeal carcinoma is an aggressive tumor that currently has no FDA-approved immuno-oncology treatment options, and we believe that toripalimab in combination with chemotherapy, if approved, will establish a new standard of care for first line treatment of advanced NPC,” said Denny Lanfear, CEO of Coherus, in a press release. “Toripalimab is the PD-1 cornerstone of our immuno-oncology strategy, and we are pleased that the FDA has accepted the BLA for review. Including the toripalimab application, Coherus now has 3 product candidate BLAs under review by the FDA, and our team is making rapid progress toward our goal to diversify and expand our commercial product portfolio.”

The BLA for toripalimab is supported by the results from clinical studies POLARIS-02 and JUPITER-02, which were both multi-center, open-label, double blind, placebo-controlled trials.

The priority review comes with a 6-month target action date compared to a 10-month standard review timeline.

REFERENCE

Coherus and Junshi Biosciences Announce FDA Acceptance of BLA Filing for Toripalimab for Treatment of Nasopharyngeal Carcinoma. Coherus Biosciences. November 1, 2021. Accessed November 3, 2021. https://investors.coherus.com/news-releases/news-release-details/coherus-and-junshi-biosciences-announce-fda-acceptance-bla