US FDA Approves LENVIMA For Unresectable Liver Cancer

Lenvatinib mesylate was shown to improve overall survival in patients with unresectable liver cancer.

AsianScientist (Sep. 6, 2018) – The US Food and Drug Administration has approved the kinase inhibitor LENVIMA® (lenvatinib mesylate) for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).

Liver cancer is the second leading cause of cancer-related death and is estimated to be responsible for 750,000 deaths per year globally, with 780,000 cases newly diagnosed each year. HCC accounts for 85 to 90 percent of liver cancer cases. Treatment options for unresectable HCC are limited and the prognosis for patients is very poor, making this an area of high unmet medical need.

The approval of LENVIMA was based on results from the REFLECT (Study 304), where LENVIMA demonstrated a proven treatment effect on overall survival (OS)—patients treated with LENVIMA experienced a median OS of 13.6 months compared to 12.3 months with sorafenib, another approved drug for the treatment of unresectable HCC.

Additionally, LENVIMA outperformed sorafenib in median progression-free survival (7.3 months in patients receiving LENVIMA versus 3.6 months for those on sorafenib).

“Unresectable hepatocellular carcinoma is an extremely difficult-to-treat cancer, with no new first-line systemic therapy options for more than a decade,” said Dr. Ghassan Abou-Alfa, a medical oncologist at Memorial Sloan Kettering Cancer Center.

“REFLECT is the first-ever positive Phase III trial against an active comparator in unresectable HCC. The efficacy and safety data from REFLECT are important findings for oncologists and others in the multidisciplinary teams who treat liver cancer, as well as for our patients who are affected by it.”

This is the second approval of LENVIMA for use in the treatment of HCC following approval in Japan earlier this year, and the first new systemic therapy to be approved in the US for the first-line treatment of unresectable HCC in approximately ten years.


Source: Eisai; Photo: Shutterstock.
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