Merck's (MRK) Keytruda gains FDA approval for hepatocellular carcinoma (HCC) in patients previously treated with sorafenib.
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Merck & Co., Inc. MRK announced that the FDA has granted approval to a supplemental new drug application (sBLA) looking to expand the label of its PD-L1 inhibitor, Keytruda.


Keytruda received approval for this filing, on an accelerated basis, for the treatment of advanced hepatocellular carcinoma (HCC), the most common type of liver cancer in patients, previously treated with Bayer/Amgen’s AMGN Nexavar (sorafenib). Continued approval for the indication will depend on confirmation of the clinical benefit in confirmatory studies.

The sBLA filing was based on data from the phase II KEYNOTE-224 study. The outcomes data from the study demonstrated that treatment with Keytruda monotherapy led to an overall response rate (ORR) of 17% in patients with advanced HCC. The data also showed a 1% complete response rate and a 16% partial response rate as a result of treatment with Keytruda.

So far this year, Merck’s shares have outperformed the industry. Merck’s shares have risen 33% in the period compared with 8.3% increase for the industry.