FDA approves Cyramza for treatment of metastatic colorectal cancer

April 28, 2015

FDA has approved Cyramza (ramucirumab, Eli Lilly) injection for the treatment of metastatic colorectal cancer with disease progression on or after prior therapy.

FDA has approved Cyramza (ramucirumab, Eli Lilly) injection for the treatment of metastatic colorectal cancer with disease progression on or after prior therapy.

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Colorectal cancer (CRC) originates in the colon or rectum and metastatic colorectal cancer (mCRC) occurs when the disease spreads to at least 1 distant organ, such as the liver or lungs. CRC is the second leading cause of cancer death in the United States and the 5-year survival rate for patients diagnosed with metastatic disease is 12.9%.

Cyramza is a recombinant monoclonal antibody that inhibits vascular endothelial growth factor receptor-2 (VEGFR-2). The drug binds the receptor and prevents the binding of normal VEGF ligands ultimately resulting in reduced tumor vascularity and growth.

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With the new label expansion, Cyramza is now approved for use with FOLFIRI (irinotecan, folinic acid, and f-fluorouracil) chemotherapy for the treatment of patients with metastatic colorectal cancer (mCRC) with disease progression after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimdine.

This is the fourth FDA approval for Cyramza; it is also indicated in metastatic gastric or gastroesophageal adenocarcinoma and in metastatic non-small cell lung cancer.

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"Cyramza now has approvals in advanced or metastatic forms of three of the world's most common and deadly cancers-gastric, non-small cell lung, and colorectal-with 4 FDA approvals received in just over a year," said Sue Mahony, PhD, senior vice president and president, Lilly Oncology, said in a press release. "This progress is encouraging and supports our ongoing development program for Cyramza. Achieving today's milestone is another example of Lilly's commitment to people living with gastrointestinal cancers."

The new approval is based on the phase 3 RAISE trial, which compared Cyramza plus FOLFIRI to placebo plus FOLFIRI in patients with mCRC previously treated with bevacizumab, oxaliplatin, and a fluoropyrimidine. The trial looked at overall survival (OS) as well as progression-free survival (PFS). Cyramza plus FOLFIRI resulted in a statistically significant improvement in both outcome measures compared to placebo plus FOLFIRI.

The most common adverse reactions associated with the use of Cyramza in the RAISE trial included diarrhea, neutropenia, decreased appetite, epistaxis, and stomatitis. Cyramza’s labeling also contains Boxed Warnings for hemorrhage, GI perforation, and impaired wound healing. 

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