Ipilimumab
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Non-small cell lung cancer1 | |||
No sensitising EGFR mutation or ALK translocation | + nivolumab and 2 cycles of platinum-based chemotherapy | 1L metastatic | None |
| Mesothelioma1 | |||
None | + nivolumab | 1L advanced | Pleural mesothelioma only |
| Colorectal cancer2 | |||
Mismatch repair deficient or microsatellite instability-high | + nivolumab | 1L advanced | None |
Mismatch repair deficient or microsatellite instability-high | + nivolumab | 2L metastatic | After prior fluoropyrimidine-based combination chemotherapy |
| Oesophageal cancer1 | |||
Tumour cell PD-L1 expression ≥ 1% | + nivolumab | 1L advanced | Squamous cell carcinoma only |
| Hepatocellular carcinoma1 | |||
None | + nivolumab | 1L advanced | None |
| Renal cell carcinoma1 | |||
None | + nivolumab | 1L advanced | Intermediate/poor-risk |
| Melanoma2 | |||
None | + nivolumab | Any line advanced | None |
None | Monotherapy | Any line advanced | None |
Full text of section 4.1 (therapeutic indications)
Melanoma YERVOY as monotherapy or in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.4). Relative to nivolumab monotherapy, an increase in progression-free survival (PFS) and overall survival (OS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression (see sections 4.4 and 5.1). Renal cell carcinoma (RCC) YERVOY in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5.1). Non-small cell lung cancer (NSCLC) YERVOY in combination with nivolumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation. Malignant pleural mesothelioma (MPM) YERVOY in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. Mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC) YERVOY in combination with nivolumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high colorectal cancer in the following settings: - first-line treatment of unresectable or metastatic colorectal cancer; - treatment of metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy (see section 5.1). Oesophageal squamous cell carcinoma (OSCC) YERVOY in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%. Hepatocellular carcinoma (HCC) YERVOY in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma.
Label history
60 changes to the Yervoy label since 2012, 11 of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes