FDA approved Loqtorzi (toripalimab-tpzi) for Nasopharyngeal CarcinomaFDA approved new drug Loqtorzi for a rare head and neck cancer

FDA From the archive Source published October 27, 2023 Summary added September 3, 2026 DOI ↗ Editorial oversight: Dr. Julia Lee, PhD · Oncology, Genomics & Drug Development

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Key Takeaway

Consider toripalimab-tpzi for NPC in first-line combination and after platinum progression, with immune-related AE monitoring.

The FDA has approved toripalimab-tpzi (Loqtorzi), a PD-1-blocking antibody, for the treatment of nasopharyngeal carcinoma (NPC). This is the first FDA-approved therapy for NPC, a cancer that is rare in the United States but more common in endemic regions. The approval covers two distinct indications: first-line treatment in combination with cisplatin and gemcitabine for adults with metastatic or recurrent locally advanced NPC, and as a single agent for adults with recurrent unresectable or metastatic NPC who have progressed on or after platinum-containing chemotherapy.

This approval provides a new standard-of-care option for a disease with limited treatment options. The combination regimen addresses the first-line setting, while the single-agent indication offers a subsequent therapy for patients who have progressed. Clinicians should note the different dosing schedules for each indication and the need to monitor for immune-mediated adverse reactions.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Toripalimab-tpzi is a programmed death receptor-1 (PD-1)-blocking antibody that binds to PD-1 and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.

Indication & Patient Population

Loqtorzi is indicated in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC). It is also indicated 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.

Dosing & Administration

For first-line NPC, the recommended dose is 240 mg intravenously every three weeks until disease progression, unacceptable toxicity, or up to 24 months. For recurrent NPC, the recommended dose is 3 mg/kg intravenously every two weeks until disease progression or unacceptable toxicity. The first infusion should be administered over 60 minutes; subsequent infusions may be given over 30 minutes if no infusion-related reactions occurred during the first infusion. No dose reductions are recommended. Dosage modifications for adverse reactions are detailed in the label, including withholding or permanently discontinuing for immune-mediated reactions based on severity.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Warnings include severe and fatal immune-mediated adverse reactions, such as pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, exfoliative dermatologic conditions, myocarditis, and neurological toxicities. Infusion-related reactions may occur. The label provides specific dosage modification guidelines for these reactions. No contraindications are listed in the label.

Place in Therapy

Loqtorzi is the first PD-1 inhibitor approved for nasopharyngeal carcinoma. It offers a new first-line option in combination with chemotherapy and a single-agent option for previously treated patients. Clinicians should consider this agent in appropriate patients, with attention to dosing schedules and immune-related adverse event management.

The U.S. Food and Drug Administration (FDA) has approved a new medicine called Loqtorzi (toripalimab-tpzi) for adults with nasopharyngeal carcinoma (NPC), a type of cancer that starts in the upper part of the throat behind the nose. This is the first FDA-approved therapy for this disease, which is rare in the United States but more common in parts of Asia and Africa.

Loqtorzi is approved for two situations. First, it can be used together with two chemotherapy drugs (cisplatin and gemcitabine) as the first treatment for adults whose NPC has spread to other parts of the body or has come back after initial treatment. Second, it can be used alone for adults whose cancer did not get better or got worse after they received chemotherapy that included a platinum drug.

This approval is important because patients with NPC have had very few treatment options. Loqtorzi works by helping the immune system fight the cancer. It is given as an intravenous infusion, and the dosing schedule depends on which situation it is used for. As with other similar drugs, Loqtorzi can cause side effects related to the immune system, so doctors will monitor patients closely.

If you or a loved one has NPC, talk to your doctor about whether Loqtorzi might be an option. This approval provides a new standard of care, but it is not a cure. Your healthcare team can help you understand the potential benefits and risks based on your specific situation.

What this means for you:

Loqtorzi is a new FDA-approved option for a rare throat cancer, but talk to your doctor to see if it's right for you.

Study Details

Study typeFda approval

PublishedOct 2023

View Original Abstract ↓

1 INDICATIONS AND USAGE 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) ( 1.1 ) 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 ( 1.2 ) 1.1 First-line Treatment of Metastatic or Recurrent, Locally Advanced NPC with Cisplatin and Gemcitabine LOQTORZI is indicated, in combination with cisplatin and gemcitabine, for the first-line treatment of adults with metastatic or with recurrent, locally advanced nasopharyngeal carcinoma (NPC). 1.2 Previously Treated Unresectable or Metastatic NPC LOQTORZI is indicated, 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.

FDA approved Loqtorzi (toripalimab-tpzi) for Nasopharyngeal CarcinomaFDA approved new drug Loqtorzi for a rare head and neck cancer

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