Drug-maker Eli Lilly and Co. has received approval from the US Food and Drug Administration for gastric cancer drug Cyramza (ramucirumab) to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma. The gastric cancer drug Cyramza (ramucirumab) is a single-agent treatment for advanced gastric cancer following disease progression after initial chemotherapy.

The drug was selected for a priority review by the FDA in late 2013 and the decision over its approval was expected to come out in the second quarter of 2014.

The approval is important for the pharmaceutical company as Cyramza marks the first FDA-approved treatment for patients in this condition. Lilly is looking forward to make this drug available over the next few weeks and will offer patient assistance programs to eligible patients receiving Cyramza treatment.

"Lilly Oncology is committed to delivering innovative medicines that extend the lives of people with cancer. Until now, there were no FDA-approved options for patients in this indication", said Richard Gaynor, MD, senior vice-president, product development and medical affairs for Lilly Oncology.

The FDA gave its approval for Cyramza or ramucirumab injection 10 mg/ml solution after looking into the results of the first Phase III trial with either a single-agent biologic or an anti-angiogenic therapy. The trial was named as REGARD, which is a multicenter, randomized, placebo-controlled, double-blind trial of patients who are suffering from locally advanced or metastatic gastric cancer and has previously received treatment with fluoropyrimidine-or platinum-containing chemotherapy.

A biologic agent was found to improve overall survival and progression-free survival in patients with advanced gastric cancer after prior chemotherapy.

Gaynor said that they are elated over FDA's decision to approve CYRAMZA for these patients. The disease is an aggrieve one and presents plethora of problems during treatment and the prognosis is often very poor in these cases.