FDA Grants Bayer Priority Review for Stivarga® (regorafenib)

Whippany-based Bayer announced that the US Food and Drug Administration (FDA) has granted priority review status for the supplemental New Drug Application (sNDA) for Stivarga® (regorafenib) tablets for the second-line systemic treatment of patients with hepatocellular carcinoma (HCC) in the US.

HCC is the most common form of liver cancer, a disease that affects nearly 40,000 patients in the United States and is the second deadliest form of cancer worldwide.

“Liver cancer is one of the few cancers still on the rise, and though Nexavar® (sorafenib) has been approved for the treatment of patients with unresectable HCC since 2007, effective second-line systemic treatment options are urgently needed,” said Dario Mirski, M.D., Bayer’s senior vice president and head of medical affairs for the Americas. “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.”

The FDA grants priority review to medicines that, if approved, would provide significant improvements in the safety or effectiveness of the treatment for serious conditions. Under the Prescription Drug User Fee Act (PDUFA), the FDA aims to complete its review within six months (compared to 10 months under standard review).

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.

The sNDA is based on data from the international, multicenter, placebo-controlled Phase III RESORCE trial which investigated Stivarga in patients with HCC whose disease had progressed during treatment with Nexavar.

Stivarga has also been submitted to regulatory authorities in Japan and the EU for the treatment of second-line HCC.

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