FDA Grants Accelerated Approval for Combination Treatment for HCC
The US Food and Drug Administration granted accelerated approval to the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
Approval was based on results from a multicenter, multiple cohort, open-label trial in patients with HCC who progressed on or were intolerant to sorafenib. Patients (N = 49) received nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg every 3 weeks for 4 weeks, followed by single-agent nivolumab 240 mg every 2 weeks until disease progression or unacceptable toxicity.
The overall response rate was 33% (n=16; 95% CI: 20, 48), with 4 complete responses and 12 partial responses. Response duration ranged from 4.6 to 30.5+ months, with 31% of responses lasting at least 24 months.
Read the full press release here.