Toripalimab

Toripalimab (Loqtorzi, Topalliance Biosciences Europe Limited) has 2 EU-approved indications in 2 tumour types.
Approved indications of Toripalimab
Biomarker requirementRegimenSettingConditions
Oesophageal cancer1
None
+ cisplatin and paclitaxel
1L
advanced
Squamous cell carcinoma only
Nasopharyngeal carcinoma1
None
+ cisplatin and gemcitabine
1L
advanced
Recurrent disease not amenable to surgery or radiotherapy
Full text of section 4.1 (therapeutic indications)

LOQTORZI, in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic nasopharyngeal carcinoma. LOQTORZI, in combination with cisplatin and paclitaxel, is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma.

Label history

5 changes to the Loqtorzi label since 2025, none of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes