Bayer submits Stivarga sNDA to FDA

Bayer has submitted its supplemental New Drug Application (sNDA) for Stivarga tablets to the U.S. Food and Drug Administration (FDA).
Stivarga tablets, also known as regorafenib, were designed for patients who have unresectable hepatocellular carcinoma (uHCC) as a second-line systemic treatment.
"For nearly a decade and counting, Bayer has been committed to meeting the needs of those with liver cancer with our proven first-line systemic therapy in unresectable HCC patient's therapy, Nexavar," Bayer’s Senior Vice President Dr. Dario Mirski said. "Clearly, more options are needed for these patients, especially in the second-line setting. The filing of Stivarga in HCC demonstrates our commitment to ongoing research in this difficult-to-treat cancer."
Stivarga tablets have already received approval from the FDA to treat patients with metastatic colorectal cancer (mCRC) who received prior fluoropyrimidine treatments.
"Regorafenib is the first treatment to demonstrate overall survival benefit in the second-line setting for unresectable HCC in clinical trials and, if approved, has the potential to change the treatment landscape for patients who progress on sorafenib," Dr. Jordi Bruix, of the BCLC Group’s Liver Unit and Hospital Clinic at the University of Barcelona, said.