Quick answers
- What is Toripalimab-tpzi used for?
- The FDA-approved label (Loqtorzi, Coherus Oncology, Inc., July 23, 2026) says: “LOQTORZI is a programmed death receptor-1 (PD-1)- blocking antibody indicated: in combination with cisplatin and gemcitabine, for first-line treatment of adults with metastatic or with recurrent locally advanced nasopharyngeal carcinoma (NPC) as a single agent for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy 1.1 …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Toripalimab-tpzi have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Toripalimab-tpzi?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Toripalimab-tpzi been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Toripalimab-tpzi?
- 1 company lists prescription products of Toripalimab-tpzi in the FDA NDC Directory, including Coherus Oncology, Inc..
What Toripalimab-tpzi is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
LOQTORZI is a programmed death receptor-1 (PD-1)- blocking antibody indicated: in combination with cisplatin and gemcitabine, for first-line treatment of adults with metastatic or with recurrent locally advanced nasopharyngeal carcinoma (NPC) as a single agent for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy 1.1 …
— FDA label: Loqtorzi, Coherus Oncology, Inc., effective July 23, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Injection |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Loqtorzi |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Coherus Oncology, Inc.1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA761240 LOQTORZI | Coherus Biosciences Inc | October 27, 2023 | 3, latest August 31, 2026 2026: Labeling · 2024: Labeling · 2024: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2669413, 2669420 |
|---|---|
| SPL set ID of the quoted label | 82e7921a-1e84-4988-9799-0ad7d19b2a75 |
| FDA labels (SPL) | 1 |
| FDA applications | BLA761240 |
| Active ingredients (FDA) | TORIPALIMAB |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Loqtorzi, Coherus Oncology, Inc., effective July 23, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →