Toripalimab
A Chinese-developed PD-1 blocker that became the first immunotherapy approved in the US for nasopharyngeal cancer.
Approved by the FDA 27 October 2023 with gemcitabine-cisplatin for first-line recurrent or metastatic NPC and as monotherapy after platinum (JUPITER-02, POLARIS-02); EU approval 2024 for NPC and oesophageal squamous cell carcinoma. Broadly approved in China across lung, oesophageal, urothelial, and other cancers. Junshi Biosciences; Coherus in the US.
1.Binds PD-1 on T cells and blocks PD-L1/PD-L2 engagement
- Route
- Intravenous
- Schedule
- 240 mg every 3 weeks with gemcitabine-cisplatin for up to 6 cycles, then maintenance
- Monitoring
- Immune-related adverse events; thyroid function
Source: www.accessdata.fda.gov/drugsatfda_docs/label/2023/761240s000lbl.pdf. Doses are for orientation; the current label governs.
- Medicare
- Part B (clinician-administered)
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. FDA-approved for nasopharyngeal carcinoma.
- Commercial insurance
- covered with prior authorisation
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
- Notes
- MHRA-licensed 2025 for nasopharyngeal carcinoma; NICE position not yet researched.
Sources: NICE search: toripalimab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
- 27 Oct 2023ApprovalUS
First FDA approval for nasopharyngeal carcinoma
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2023 | Recurrent/metastatic nasopharyngeal carcinoma, first line with chemotherapy and later lines |
| China | 2018 | Melanoma (first of many indications) |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery for this drug: (TITLE:"Toripalimab" OR ABSTRACT:"Toripalimab" OR TITLE:"Loqtorzi" OR ABSTRACT:"Loqtorzi") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Toripalimab, not a curated reading list.