FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

Lilly Wins Approval for Liver Cancer Treatment

May 23, 2019
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Eli Lilly has won FDA approval for its Cyramza in liver cancer patients, the first biomarker-driven therapy of its kind.

Cyramza (ramucirumab injection) is approved for patients with hepatocellular carcinoma who have an alpha-fetoprotein (AFP) level at or below 400 ng per ml and who have already been treated with sorafenib. AFP is a biomarker that can be assessed through a blood tests, which Lilly officials say makes it much easier to determine treatment options for patients.

The approval comes after Lilly handed up results from a Phase 3 study which selected patients based on their AFP levels. Cyramza was previously approved, singly or in combination, for gastric, non-small cell lung, colorectal and hepatocellular cancers.

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