FDA approvals

FDA approves Cyramza for stomach cancer

The FDA today approved ramucirumab for treatment of patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma.

Ramucirumab (Cyramza, Eli Lilly), an angiogenesis inhibitor that blocks the blood supply to tumors, is indicated for patients with unresectable disease, or for those whose disease metastasized after treatment with platinum- or fluoropyrimidine-containing therapy.

The FDA approved ramucirumab under its priority review program, which allows for expedited review of agents that demonstrate the potential to offer a major advance in treatment or provide a treatment where no adequate therapy exists. The FDA also granted orphan drug status to ramucirumab because it is intended to treat a rare condition.

An estimated 22,220 people in the United States will be diagnosed with stomach cancer this year, and 10,990 people will die of the disease.

Richard Pazdur, MD 

Richard Pazdur

“Although the rates of stomach cancer in the United States have decreased over the past 40 years, patients require new treatment options, particularly when they no longer respond to other therapies,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “Cyramza is new treatment option that has demonstrated an ability to extend patients’ lives and slow tumor growth.”

The FDA based its approval in part on results of a trial that included 355 people with unresectable or metastatic stomach or gastroesophageal junction cancer. Researchers assigned patients in a 2:1 ratio to ramucirumab or placebo. OS served as the primary endpoint.

Patients assigned ramucirumab demonstrated longer median OS (5.2 months vs. 3.8 months) and longer median PFS.

Results of a second trial demonstrated patients who received ramucirumab plus paclitaxel survived longer than those who received paclitaxel alone.

Adverse events frequently reported by patients treated with ramucirumab include diarrhea and high blood pressure, according to the FDA.

The FDA today approved ramucirumab for treatment of patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma.

Ramucirumab (Cyramza, Eli Lilly), an angiogenesis inhibitor that blocks the blood supply to tumors, is indicated for patients with unresectable disease, or for those whose disease metastasized after treatment with platinum- or fluoropyrimidine-containing therapy.

The FDA approved ramucirumab under its priority review program, which allows for expedited review of agents that demonstrate the potential to offer a major advance in treatment or provide a treatment where no adequate therapy exists. The FDA also granted orphan drug status to ramucirumab because it is intended to treat a rare condition.

An estimated 22,220 people in the United States will be diagnosed with stomach cancer this year, and 10,990 people will die of the disease.

Richard Pazdur, MD 

Richard Pazdur

“Although the rates of stomach cancer in the United States have decreased over the past 40 years, patients require new treatment options, particularly when they no longer respond to other therapies,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “Cyramza is new treatment option that has demonstrated an ability to extend patients’ lives and slow tumor growth.”

The FDA based its approval in part on results of a trial that included 355 people with unresectable or metastatic stomach or gastroesophageal junction cancer. Researchers assigned patients in a 2:1 ratio to ramucirumab or placebo. OS served as the primary endpoint.

Patients assigned ramucirumab demonstrated longer median OS (5.2 months vs. 3.8 months) and longer median PFS.

Results of a second trial demonstrated patients who received ramucirumab plus paclitaxel survived longer than those who received paclitaxel alone.

Adverse events frequently reported by patients treated with ramucirumab include diarrhea and high blood pressure, according to the FDA.