On Monday, German conglomerate Bayer A/G announced the submission of a New Drug Application to the US Food and Drug Administration. The application is for regorafenib (under the brand name Stivarga, a tablet aimed to act as a second-line systemic treatment for patients with unresectable hepatocellular carcinoma (uHCC).
The drug has already been approved for—and is currently in use by—patients who have been diagnosed with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. This is an anti-VEGF therapy. The tablet has also been approved to treat patients who have locally advanced, unresectable, or metastatic gastrointestinal stromal tumor who have been previously treated with imatinib mesylate and sutinib maleate.
“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,” comments Bayer senior vice president Dario Mirski, who is also the company’s head of medical affairs for the Americas. “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.”
The company also goes on to explain the have submitted the new sNDA applications because of favorable data out of the international, multicenter, placebo-controlled Phase III RESORCE trial. This trial looked at Stivarga in patients who have been diagnosed with unresectable HCC and whose disease had progressed even during treatment with with Nexavar® (sorafenib) tablets.
Furthermore, Dr. Jordi Buix—of the BCLC Group, Liver Unit, Hospital Clinic, at the University of Barcelona, IDIBAPS, CIBEREHD, in Spain—notes, “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 Bruix is also the lead investigator of the RESORCE study as well as the SHARP Phase III study that aims to investigate sorafenib in unresectable HCC.
Globally, there are about 780,000 HCC diagnoses every year, and this number continues to rise. In the United States, alone, this cancer has more than tripled since 1980. Liver cancer is now the second leading cause of cancer-related deaths in the world.