Bayer has announced that their supplemental New Drug Application (sNDA) for Stivarga (regorafenib tablets) has been granted priority review status by the Food and Drug Administration (FDA).
The sNDA is for the second-line systemic treatment of patients with hepatocellular carcinoma (HCC). The sNDA is based on data from the multicenter, placebo-controlled Phase III RESORCE trial which investigated Stivarga in 573 patients with HCC whose disease progressed during sorafenib treatment.
“The priority review for Stivarga paves the way for us to gain regulatory approval as early as possible for the HCC patients who need it most,” said Dario Mirski, MD, and SVP of Bayer.
Stivarga is currently approved to treat patients with metastatic colorectal cancer (mCRC) who have previously been treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and an anti-EGFR therapy. It is also approved to treat patients with locally advanced, unresectable, or metastatic gastrointestinal stromal tumor (GIST) who were previously treated with imatinib mesylate and sunitinib malate.
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