Eli Lilly has obtained US Food and Drug Administration approval for its 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.
According to Lilly, approval of Cyramza (ramucirumab injection 10mg/ml solution) makes the drug the first FDA-approved treatment for patients with advanced gastric cancer after prior chemotherapy.
Approval of Cyramza is based on positive data from REGARD, a Phase III study of Cyramza and best supportive care (BSC) compared with placebo and BSC as gastric cancer, including gastroesophageal junction adenocarcinoma following progression after initial fluoropyrimidine- or platinum-containing chemotherapy.
The double-blinded, placebo-controlled Phase III study randomised 355 patients in 29 countries. The study's primary endpoint was overall survival, while the secondary endpoint was progression-free survival.
Lilly claims that it is the first Phase III trial to demonstrate improved overall survival and progression-free survival with a biologic agent in advanced gastric cancer after prior chemotherapy.
The most commonly reported adverse reactions observed in the REGARD study were hypertension, diarrhoea, a headache, and hyponatremia. The most common serious adverse events with Cyramza were anemia and intestinal obstruction.
"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."
A vascular endothelial growth factor (VEGF) Receptor 2 antagonist, Cyramza specifically binds and blocks activation of VEGF Receptor 2 and blocks binding of VEGF receptor ligands VEGF-A, VEGF-C, and VEGF-D. Cyramza inhibited angiogenesis in an in-vivo animal model.
According to Lilly, FDA approval of Cyramza marks a regulatory milestone in the company's R&D programme for the molecule, which it acquired when it purchased ImClone Systems in 2008. The FDA granted Orphan Drug Designation to Cyramza for this indication.
Lilly Oncology product development and medical affairs senior vice-president Dr Richard Gaynor said that there were no previously FDA-approved options for patients in this indication.
"We are pleased that the FDA has approved Cyramza for these patients," Dr Gaynor said. This is an aggressive disease that is difficult to treat, and the prognosis has typically been very poor."
Lilly anticipates making Cyramza available in the coming weeks.