Merck: FDA rejects liver cancer treatment
(CercleFinance.com) - Merck and Japan's Eisai on Wednesday said that the US Food and Drug Administration did not approve their new drug application for a combination of Keytruda and Lenvima as first-line treatment for unresectable hepatocellular carcinoma.
The companies said they received a so-called "complete response letter" detailing the FDA's reasons for rejection.
The drugmakers said they now plan to work with the FDA to conduct a well-controlled clinical trial that demonstrates substantial evidence of the combination's effectiveness and the clinical benefit.
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The companies said they received a so-called "complete response letter" detailing the FDA's reasons for rejection.
The drugmakers said they now plan to work with the FDA to conduct a well-controlled clinical trial that demonstrates substantial evidence of the combination's effectiveness and the clinical benefit.
Copyright (c) 2020 CercleFinance.com. All rights reserved.