Eli Lilly receives marketing authorization from the European Commission for Cyramza
US pharma major Eli Lilly (NYSE: LLY) has received marketing authorization from the European Commission for its drug Cyramza (ramucirumab).
The drug is the first licensed therapy specifically for adult patients with advanced gastric or gastro-esophageal junction adenocarcinoma, following prior chemotherapy.
Ramucirumab is approved in combination with paclitaxel chemotherapy and as a single agent in patients who cannot take paclitaxel. The approval is based on two international Phase III studies which showed an extended overall survival time and delayed disease progression versus each study comparator. The study program involved 1,020 patients, and results from the RAINBOW study showed ramucirumab with paclitaxel extended overall survival time to 9.6 months, compared to 7.4 months for placebo and paclitaxel.
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