Ramucirumab

Ramucirumab (Cyramza, Eli Lilly Nederland B.V.) has 6 EU-approved indications in 4 tumour types. 2 need a biomarker result: AFP (1) and EGFR (1).
Approved indications of Ramucirumab
Biomarker requirementRegimenSettingConditions
Non-small cell lung cancer2
EGFR mutation
+ erlotinib
1L
metastatic
None
None
+ docetaxel
2L
advanced
After platinum-based chemotherapy
Colorectal cancer1
None
+ FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil)
2L
metastatic
After bevacizumab, oxaliplatin and a fluoropyrimidine
Gastric and GEJ adenocarcinoma2
None
+ paclitaxel
2L
advanced
After platinum and fluoropyrimidine chemotherapy
None
Monotherapy
2L
advanced
After platinum or fluoropyrimidine chemotherapy; For whom treatment in combination with paclitaxel is not appropriate
Hepatocellular carcinoma1
Serum AFP ≥ 400 ng/ml
Monotherapy
2L
advanced
After sorafenib
Full text of section 4.1 (therapeutic indications)

Gastric cancer Cyramza in combination with paclitaxel is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum and fluoropyrimidine chemotherapy (see section 5.1). Cyramza monotherapy is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum or fluoropyrimidine chemotherapy, for whom treatment in combination with paclitaxel is not appropriate (see section 5.1). Colorectal cancer Cyramza, in combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil), is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin and a fluoropyrimidine. Non-small cell lung cancer Cyramza in combination with erlotinib is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer with activating epidermal growth factor receptor (EGFR) mutations (see section 5.1). Cyramza in combination with docetaxel is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with disease progression after platinum-based chemotherapy. Hepatocellular carcinoma Cyramza monotherapy is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma who have a serum alpha fetoprotein (AFP) of ≥ 400 ng/ml and who have been previously treated with sorafenib.

Label history

26 changes to the Cyramza label since 2016, 4 of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes