Shots:

• The approval is based on P-III CELESTIAL study results assessing Cabometyx (60 mg- qd) vs PBO in 760 patients in a ratio (2:1) with 2L advanced HCC who previously received sorafenib
• P-III CELESTIAL study results: mOS (10.2 vs 8.0 mos.); mPFS (5.2 vs 1.9 mos.); ORR (4% vs 0.4%); Disease control (64% vs 33%)- Presented at ASCO-GI Jan- 2018
• Cabometyx (cabozantinib)is a TKI approved by the US FDA and EU for renal cell carcinoma (RCC) & advanced RCC in adults received prior VEGF-targeted therapy respectively. In Dec  2018- Exelixis initiated P-III COSMIC-312 study for evaluation of cabozantinib + atezolizumab vs sorafenib in 1L untreated advanced HCC

Ref: Exelixis| Image: Coa Pharmacy