Lilly's Cyramza (Ramucirumab) Becomes First FDA-Approved Treatment for Advanced Gastric Cancer After Prior Chemotherapy

Eli Lilly and Company has announced that the FDA has approved Cyramza (ramucirumab) as a single-agent treatment for patients with advanced or metastatic gastric cancer or gastroesophageal junction (GEJ) 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," said Richard Gaynor, MD, senior vice president, 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."

The Cyrmaza (ramucirumab injection 10 mg/mL solution) approval is based on results of REGARD, a multicenter, randomized, placebo-controlled, double-blind trial of patients with locally advanced or metastatic gastric cancer including GEJ adenocarcinoma previously treated with fluoropyrimidine- or platinum-containing chemotherapy. It is the first Phase III trial to show improved overall survival and progression-free survival with a biologic agent in advanced gastric cancer after prior chemotherapy. Results demonstrated that Cyramza (8 mg/kg by infusion every 2 weeks) plus best supportive care (BSC), as compared with placebo plus BSC, increased the median overall survival of patients with advanced gastric cancer by 37% (median overall survival of 5.2 months [95% confidence interval (CI) 4.4, 5.7] vs. 3.8 months [95% CI 2.8, 4.7] for placebo, P=0.047, hazard ratio 0.78 [95% CI 0.60, 0.998]).

In addition, Cyramza significantly improved progression-free survival, demonstrating a 62% increase in median progression-free survival (2.1 months [95% CI 1.5, 2.7] vs. 1.3 months [95% CI 1.3, 1.4] for placebo, P < 0.001, hazard ratio 0.48 [95% CI 0.38, 0.62]).

"There is a high unmet medical need in patients with this disease," said Charles Fuchs, M.D., M.P.H., 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."

"As someone who has experienced firsthand the limited options available to treat this devastating disease, I consider this approval to be much needed. This is a significant moment for many patients and their families," said Debbie Zelman, president and founder of a leading international patient advocacy organization, Debbie's Dream Foundation, which is dedicated to raising awareness about gastric cancer, advancing funding for research, and providing education and support to those affected by the disease. Zelman founded the organization following her own gastric cancer diagnosis. Lilly Oncology and Debbie's Dream Foundation have established a partnership to improve patient and caregiver awareness of and access to gastric cancer resources.

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 US by the FDA's Office of Orphan Products Development (OOPD) 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 programmes for eligible patients receiving Cyramza treatment.