The next China-developed immuno-oncology therapy to cross the FDA’s desk has been hit with bad news. Still, it will be half a year at least before Coherus BioScience and Junshi Bioscience get another crack at U.S. approval of their cancer PD-1 inhibitor, toripalimab.
The FDA has turned away Coherus’ Junshi-licensed prospect for head and neck cancer, coming after the FDA snubbed sintilimab, a China-developed PD-1 inhibitor from Eli Lilly and Innovent Biologics. Currently, there are no approved head and neck cancer immunotherapies in the U.S., which the FDA has noted warrants “flexibility” for toripalimab’s approval decision, Coherus and Junshi said.
