FDA approves Eli Lilly orphan drug for gastric cancer

INDIANAPOLIS — Eli Lilly on Monday announced that the Food and Drug Administration has approved Cyramza (ramucirumab) as a single-agent treatment for patients with advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with 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.

"Lilly Oncology is committed to delivering innovative medicines that extend the lives of people with cancer," stated Richard Gaynor, SVP product development and medical affairs for Lilly Oncology. "Until now, there were no FDA-approved options for patients in this indication. We are pleased that the FDA has approved Cyramza for these patients. This is an aggressive disease that is difficult to treat, and the prognosis has typically been very poor."

"There is a high unmet medical need in patients with this disease," added Charles Fuchs, principal investigator of the REGARD trial and director, Gastrointestinal Malignancy Program, Dana-Farber Cancer Institute. "This approval represents a meaningful advance for patients and gives those of us who treat them an important new second-line treatment option."

FDA approval of Cyramza marks a pivotal 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. Orphan drug status is given in the U.S. by the FDA's Office of Orphan Products Development to medicines that show promise for the treatment of rare diseases. Lilly expects to make Cyramza available in the coming weeks and is committed to offering patient assistance programs for eligible patients receiving Cyramza treatment.