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news.Eli Lilly and Company has received the US Food and Drug Administration (FDA) approval for Cyramza (ramucirumab) in combination with paclitaxel (a type of chemotherapy) to treat advanced or metastatic gastric (stomach) or gastroesophageal junction (GEJ) adenocarcinoma.
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The approval of this combination regimen is for patients whose cancer has progressed on or after prior fluoropyrimidine- or platinum-containing chemotherapy.
The FDA approval is based on data from a multinational, randomized, double-blinded, placebo-controlled Phase III RAINBOW trial, which compared Cyramza plus paclitaxel to placebo plus paclitaxel.
The trial’s efficacy endpoints included the major efficacy outcome measure of overall survival and the supportive efficacy outcome measures of progression-free survival and objective response rate.
Lilly Oncology senior vice-president, product development and medical affairs Richard Gaynor said: "This FDA approval of CYRAMZA represents another milestone for people battling this devastating and difficult-to-treat disease.
"Lilly is pleased to continue delivering on its commitment to provide new treatment options to people living with cancer and those who care for them."
The company said that labeling for Cyramza contains a Boxed Warning regarding increased risk of hemorrhage, including severe and sometimes fatal hemorrhagic events.