FDA Approves Combo Treatment for Stomach, GE Junction Adenocarcinoma

Ramucirumab plus paclitaxel approved to treat advanced gastric or gastroesophageal junction adenocarcinoma

(RxWiki News) The US Food and Drug Administration (FDA) today approved a new combination treatment for patients with advanced or metastatic gastric (stomach) or gastroesophageal junction (GEJ) adenocarcinoma.

The FDA approved an an intravenous (IV) medication called ramucirumab (brand name Cyramza) to be used in combination with paclitaxel (brand name Onxol) to treat advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Ramucirumab was first approved in April 2014 to treat these cancer patients, the FDA noted in a press release. But the combination of ramucirumab with paclitaxel appeared to improve survival rates in patients with these cancers.

The FDA approved the combo treatment after research showed it to be safe and effective in a trial of 665 patients who had advanced gastric or GEJ adenocarcinoma.

The patients received either the ramucirumab plus paclitaxel combo treatment or a placebo (fake treatment) plus paclitaxel. The patients who received both medications had much higher survival rates than those who only received paclitaxel and a placebo.

Patients who received the combo treatment survived for 9.6 months on average. Those who got the placebo plus paclitaxel survived for around 7.4 months.

Patients in the study did have some adverse reactions to the treatments. Those included fatigue, diarrhea, nosebleed and reduced immune system function.

Eli Lilly and Co. markets ramucirumab.


Review Date: 
November 5, 2014