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FDA Approves Second-Line Ramucirumab in AFP-Elevated HCC

Gina Columbus @ginacolumbusonc
Published: Friday, May 10, 2019

The FDA has approved ramucirumab (Cyramza) monotherapy for patients with hepatocellular carcinoma (HCC) who have an alpha fetoprotein (AFP) of ≥400 ng/ML and have been previously treated with sorafenib (Nexavar).1

 = .0059). In contrast, for patients with a baseline AFP <400 ng/mL, the median OS was 10.1 months with ramucirumab versus 11.8 months with placebo.

References

  1. FDA Approves Ramucirumab for Hepatocellular Carcinoma. FDA. Published May 10, 2019. https://bit.ly/2HeWrD7. Accessed May 10, 2019.
  2. Zhu AX, Kang Y-K, Yen C-J, et al. REACH-2: A randomized, double-blind, placebo-controlled phase 3 study of ramucirumab versus placebo as second-line treatment in patients with advanced hepatocellular carcinoma (HCC) and elevated baseline alpha-fetoprotein (AFP) following first-line sorafenib. J Clin Oncol. 2018;36 (suppl; abstr 4003).
  3. Zhu AX, Ryoo B-Y, Yen C-J, et al. Ramucirumab (RAM) as second-line treatment in patients (pts) with advanced hepatocellular carcinoma (HCC): analysis of patients with elevated α-fetoprotein (AFP) from the randomized phase III REACH study. Presented at: 2015 Gastrointestinal Cancers Symposium; January 15-17, 2015; San Francisco, CA. Abstract 232.
  4. Zhu AX, Park JO, Ryoo B-Y, et al. Ramucirumab versus placebo as second-line treatment in patients with advanced hepatocellular carcinoma following first-line therapy with sorafenib (REACH): a randomised, double-blind, multicentre, phase 3 trial. Lancet Oncol. 2015; 16(7):859-870. doi: 10.1016/S1470-2045(15)00050-9.

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