China-based Junshi Biosciences (HKG: 1877, SHA: 688180) announced that the Biologics License Application (BLA) for its programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) has been re-filed with and is under review by the US FDA. The filing covers two indications: Tuoyi’s use in combination with gemcitabine/cisplatin as a first-line treatment of advanced recurrent or metastatic nasopharyngeal carcinoma (NPC), and as a monotherapy in the second-line or later setting for NPC.
FDA Review Timeline and Requirements
The FDA has set a Prescription Drug User Fee Act (PDUFA) date of December 23, 2022, for the filing. A six-month review period for the re-filing was needed due to the requirement for an on-site inspection in China, according to the FDA, with COVID-19 disruptions recently proving problematic.
Potential US Launch and Drug Designations
If approved, Junshi’s US co-development partner Coherus BioSciences Inc., will launch Tuoyi in the first quarter of 2023 in the US, where the drug will become the first and only NPC immunotherapy in the country. The drug previously obtained two breakthrough therapy designations (BTDs), fast-track status, priority review status, and five orphan drug designations (ODDs) from the FDA for the treatment of mucosal melanoma, nasopharyngeal carcinoma, soft-tissue sarcoma, esophageal cancer, and small-cell lung cancer respectively.
Toripalimab’s Approval History and Future Prospects
Toripalimab was China’s first domestic PD-1 inhibitor to be approved (in December 2018) as a second-line treatment for melanoma. Further approvals were granted in February 2021 as a second-line treatment of NPC, in April 2021 for locally advanced or metastatic urothelial cancer (UC) in previously treated patients, in November 2021 as a first-line treatment for NPC, and in May 2022 for the treatment of unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma (ESCC) in combination with chemotherapy. Toripalimab was included on the National Reimbursement Drug List (NRDL) for the NPC and UC indications last year. In addition, the drug is awaiting regulatory decisions in China for the first-line treatment of advanced non-small cell lung cancer, again in combination with chemotherapy.-Fineline Info & Tech
