FDA Grants Priority Review for Liver Cancer Treatment

The FDA has granted priority review for the supplemental new drug application (sNDA) from Bayer for Stivarga, also known as regorafenib. The sNDA is for the use of regorafenib as a second-line systemic treatment of hepatocellular carcinoma (HCC).

Stivarga is typically used to treat patients with metastatic colorectal cancer who have previously received fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and an anti-EGFR treatment (RAS wild type) in the United States. However, it may also be used as a form of treatment in patients with a locally advanced, unresectable or metastatic gastrointestinal stromal tumor who have used imatinib mesylate and sunitinib malate.

In trials, the most common adverse reactions associated with Stivarga were fatigue, decreased appetite, and diarrhea. However, some patients also experienced hypertension, dysphonia, and infection. Stivarga also comes with a hepatotoxicity warning, which means that patients may experience potentially fatal drug-induced liver injury.

The sNDA submitted to the FDA is based on data from the phase 3 RESORCE trial, which looked at how Stivarga impacted patients who showed disease progression with Nexavar. Nexavar, also known as sorafenib, is designed to interfere with the growth and spread of cancer cells.

"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,” Dario Mirski, MD, Bayer's senior vice president and head of medical affairs for the Americas, said in a press release.