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FDA Grants Breakthrough Designation to Frontline Pembrolizumab/Lenvatinib for HCC

Gina Columbus @ginacolumbusonc
Published: Tuesday, Jul 23, 2019

The FDA has granted a breakthrough therapy designation to the combination of pembrolizumab (Keytruda) and lenvatinib (Lenvima) for the first-line treatment of patients with advanced unresectable hepatocellular carcinoma (HCC) that is not amenable to locoregional therapy.1

“We are excited that the FDA has recognized the potential of Keytruda plus Lenvima in combination in advanced unresectable hepatocellular carcinoma not amenable to locoregional treatment with this Breakthrough Therapy designation,” said Takashi Owa, MD, vice president, Chief Medicine Creation and Chief Discovery Officer, Oncology Business Group, Eisai, the manufacturer of lenvatinib. “We are dedicated to working together with Merck to potentially bring another important option to patients.”


  1. Merck and Eisai Receive Third Breakthrough Therapy Designation from FDA for KEYTRUDA (pembrolizumab) plus LENVIMA (lenvatinib) Combination Treatment. Merck. Published July 23, 2019. Accessed July 23, 2019.
  2. Ikeda M, Sung MW, Kudo M, et al. Abstract CT061: a phase Ib trial of lenvatinib (LEN) plus pembrolizumab (PEMBRO) in unresectable hepatocellular carcinoma (uHCC): updated results. Cancer Res. 2019;79(13). doi: 10.1158/1538-7445.SABCS18-CT061.

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