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Ramucirumab: A Review in Hepatocellular Carcinoma

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Abstract

Ramucirumab (Cyramza®), a fully human anti-VEGFR-2 monoclonal antibody, has been approved as monotherapy for the treatment of patients with hepatocellular carcinoma (HCC) and α-fetoprotein levels ≥ 400 ng/mL who have been treated with sorafenib. Ramucirumab significantly prolonged overall survival (OS) and progression-free survival (PFS) relative to placebo in this population in the randomized, double-blind phase 3 REACH 2 trial. These benefits were seen in key prespecified subgroups based on demographic and disease characteristics. Ramucirumab had an acceptable tolerability profile and manageable safety profile in these patients, with the majority of treatment-related adverse events being mild or moderate in severity. The safety profile of ramucirumab was consistent with that expected for agents targeting the VEGF/VEGFR axis. Currently, ramucirumab is the only therapy specifically tested in patients with α-fetoprotein levels ≥ 400 ng/mL, which is associated with an aggressive disease and poor prognosis. Therefore, ramucirumab is an important treatment option for patients with HCC and α-fetoprotein levels ≥ 400 ng/mL who have been treated with sorafenib.

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Acknowledgements

During the peer review process, the manufacturer of ramucirumab was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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Correspondence to Yahiya Y. Syed.

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The preparation of this review was not supported by any external funding.

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Yahiya Syed is a salaried employee of Adis International Ltd/Springer Nature, is responsible for the article content and declares no relevant conflicts of interest.

Additional information

Enhanced material for this Adis Drug Evaluation can be found at https://doi.org/10.6084/m9.figshare.11374896.

The manuscript was reviewed by:G. G. Di Costanzo, Department of Transplantation, Liver Unit, Cardarelli Hospital, Naples, Italy; J. Edeline, Medical Oncology Department, Centre Eugène Marquis, Rennes, France; M. Fukudo, Department of Hospital Pharmacy and Pharmacology, Asahikawa Medical University, Hokkaido, Japan; M. Nakano, Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Fukuoka, Japan; M. Peck-Radosavljevic, Department of Internal Medicine & Gastroenterology (IMuG), Hepatology, Endocrinology, Rheumatology and Nephrology with Centralized Emergency Department (ZAE), Klinikum Klagenfurt am Wörthersee, Klagenfurt, Austria; L. Rimassa, Department of Biomedical Sciences, Humanitas University, Milan, Italy; Humanitas Cancer Center, Humanitas Clinical and Research Center-IRCCS, Milan, Italy.

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Syed, Y.Y. Ramucirumab: A Review in Hepatocellular Carcinoma. Drugs 80, 315–322 (2020). https://doi.org/10.1007/s40265-020-01263-6

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