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FDA grants accelerated approval to pembrolizumab for hepatocellular carcinoma

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On November 9, 2018, the Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA, Merck & Co., Inc.) for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

Results: The confirmed ICR-assessed overall response rate was 17% (95% CI: 11, 26), with one complete response and 17 partial responses. Response durations ranged from 3.1 to 16.7 months; 89% of responders had response durations of 6 months or longer and 56% had response durations of 12 months or longer.

Adverse reactions: occurring in patients with hepatocellular carcinoma were similar to those described in KEYTRUDA product labelling; however, there were increased incidences of grade 3 or 4 ascites (8%) and immune-mediated hepatitis (2.9%). Grade 3 and 4 laboratory abnormalities that occurred at a higher incidence than in other KEYTRUDA trials were elevated AST (20%), ALT (9%), and hyperbilirubinemia (10%).

Dose: The recommended pembrolizumab dose for hepatocellular carcinoma is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks.