Bayer files Stivarga sNDA for advanced liver cancer

7 November 2016

German pharma major Bayer (BAYN: DE) today revealed it has filed a supplemental New Drug Application (sNDA) for Stivarga (regorafenib) with the US Food and Drug Administration for the second-line systemic treatment of patients with unresectable hepatocellular carcinoma (uHCC), or liver cancer.

Bayer’s shares rose 1.26% to 89.03 euros in morning trading.

Stivarga is currently approved for the treatment of patients with metastatic colorectal cancer (mCRC) who have previously been treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild type, an anti-EGFR therapy, as well as the treatment of patients with locally advanced, unresectable, or metastatic gastrointestinal stromal tumor (GIST), who were previously treated with imatinib mesylate and sutinib maleate.

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