Eli Lilly gets FDA
approval for gastric cancer combination drug
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.
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.
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