On 12 December 2019, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product ramucirumab (Cyramza).
The marketing authorisation holder for this medicinal product is Eli Lilly Nederland B.V.
The CHMP adopted a new indication as follows:
Cyramza in combination with erlotinib is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.
For information, the full indications for Cyramza will be as follows:
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.
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.
Colorectal cancer
Cyramza, in combination with irinotecan, folinic acid, and 5-fluorouracil (FOLFIRI), is indicated for the treatment of adult patients with metastatic colorectal cancer 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 NSCLC with activating EGFR mutations.
Cyramza in combination with docetaxel is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC 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 of ≥400 ng/ml and who have been previously treated with sorafenib.
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report, and will be available in all official EuropeanUnion languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.