FDA accepts Cabometyx drug application for advanced HCC
Exelixis announced that the FDA accepted a supplemental new drug application for Cabometyx tablets as a treatment for patients with previously treated advanced hepatocellular carcinoma, according to a press release.
“Patients with this aggressive form of advanced liver cancer urgently need new treatment options after they progress on first-line therapy,” Gisela Schwab, MD, president of product development and medical affairs and chief medical officer at Exelixis. “The acceptance of our sNDA filing for Cabometyx is a critical step forward as we work to help address this unmet need, and we intend to work closely with the FDA as they review the application.”
Cabometyx (cabozantinib) previously received approval to treat patients with renal cell carcinoma. Exelixis submitted the supplemental new drug application for HCC in March 2018 based on top line results from a phase 3 study.