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FDA Grants Pembrolizumab Priority Review for HCC

Jason M. Broderick @jasoncology
Published: Wednesday, Jul 11, 2018

The FDA has granted a priority review designation to a supplemental biologics license application (sBLA) for pembrolizumab (Keytruda) for previously treated patients with advanced hepatocellular carcinoma (HCC), according to Merck (MSD), the manufacturer of the PD-1 inhibitor.

Pembrolizumab has approved indications in melanoma, lung cancer, head and neck cancer, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, and cervical cancer.
Zhu AX, Finn RS, Edeline J, et al. Pembrolizumab in patients with advanced hepatocellular carcinoma previously treated with sorafenib (KEYNOTE-224): a non-randomised, open-label phase 2 trial [published online June 1, 2018]. Lancet Oncol. doi: 10.1016/S1470-2045(18)30351-6.

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