Eli Lilly and Company reported that FDA has approved Cyramza (ramucirumab) as a single-agent treatment for patients with advanced or metastatic gastric cancer or gastroesophageal junction (GEJ) adenocarcinomawith disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy. With this approval, Cyramza becomes the first FDA-approved treatment for patients in this setting.
FDA approval of Cyramza marks a regulatory milestone in Lilly's research and development program for the molecule, which it acquired when it purchased ImClone Systems in 2008. Cyramza has been granted Orphan Drug Designation by the FDA for this indication. Lilly expects to make Cyramza available in the coming weeks.
Source: Eli Lilly and Company