U.S. Food and Drug Administration Approves Exelixis's CABOMETYX Tablets for Previously Treated Hepatocellular Carcinoma
January 14, 2019 at 10:38 pm
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Exelixis, Inc. announced that the U.S. Food and Drug Administration (FDA) approved CABOMETYX (cabozantinib) tablets for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. HCC is the most common form of liver cancer and the fastest-rising cause of cancer-related death in the U.S. The FDA’s approval of CABOMETYX was based on results from the CELESTIAL phase 3 pivotal trial of CABOMETYX for patients with advanced HCC who received prior sorafenib. CABOMETYX demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus placebo. In the pivotal CELESTIAL trial, median OS was 10.2 months with cabozantinib versus 8.0 months with placebo (HR 0.76, 95% CI 0.63-0.92; p=0.0049). Median progression-free survival (PFS) was more than doubled, at 5.2 months with cabozantinib and 1.9 months with placebo (HR 0.44, 95% CI 0.36-0.52; p<0.0001). Objective response rates per RECIST 1.1 were 4% with cabozantinib and 0.4% with placebo (p=0.0086).
Exelixis, Inc. is an oncology company. The Company is engaged in developing medicines and combination regimens at the forefront of cancer care. It has produced four marketed pharmaceutical products, two of which are formulations of its flagship molecule, cabozantinib. Cabozantinib is an inhibitor of multiple tyrosine kinases, including MET, AXL, VEGF receptors and RET and has been also approved as CABOMETYX tablets for advanced renal cell carcinoma (RCC), for previously treated hepatocellular carcinoma (HCC) and for previously treated, radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC), and as COMETRIQ capsules for progressive, metastatic medullary thyroid cancer (MTC). The Company's other two products are COTELLIC, an inhibitor of MEK approved as part of multiple combination regimens to treat specific forms of advanced melanoma and MINNEBRO an oral, non-steroidal, selective blocker of the mineralocorticoid receptor (MR) approved the treatment of hypertension.
EXELIXIS, INC. 
