The FDA’s Oncologic Drug Advisory Committee voted 5 to 4 against the continued accelerated approval of nivolumab for the treatment of patients with hepatocellular carcinoma who were previously treated with sorafenib.
In an 8 to 0 vote, the FDA’s Oncologic Drug Advisory Committee opted to continue to accelerated approval of pembrolizumab for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib.
Half of all patients with hepatocellular carcinoma treated with the combination of regorafenib and nivolumab following progression on 2 lines of chemotherapy achieved disease control, according to initial results from a phase 2 proof-of-concept trial.
In a single-arm study, 100% of patients treated with sintilimab plus stereotactic body radiotherapy who had oligometastases of hepatocellular carcinoma achieved disease control and were alive and progression free at 6 months.
As part of the virtual 17th Annual Meeting of the International School of Gastrointestinal Oncology, a debate ensued around whether liver-directed or systemic therapy is best for the treatment of patients with HCC.