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www.fdanews.com/articles/171011-lillys-cyramza-wins-fourth-cancer-indication

Lilly’s Cyramza Wins Fourth Cancer Indication

May 1, 2015

Eli Lilly’s targeted antitumor drug Cyramza has snagged its fourth cancer indication from the FDA, this time as a second-line treatment for patients with metastatic colorectal cancer.

The latest win will make Cyramza (ramucirumab injection, 10 mg/mL solution) available alongside Folfiri chemotherapy to patients who have tried Roche’s Avastin (bevacizumab), Sanofi’s Eloxatin (oxaliplatin) and a fluoropyrimidine.

Cyramza, which works against proteins that allow tumors to grow new blood vessels and reproduce, also has approvals for non-small cell lung cancer, stomach cancer and as a treatment for cancer that can’t be surgically removed or has spread after treatment with a fluoropyrimidine- or platinum-containing drug.

In a global Phase III trial, patients treated with Cyramza gained 1.6 extra months of overall survival and 1.2 months of extra progression-free survival compared with patients in the other treatment arm. The FDA approved the drug in less than the usual 10 months, without granting any kind of expedited review designation, Lilly says. — Lena Freund