Merck And Eisai Receive Complete Response Letter For KEYTRUDA Plus LENVIMA Combination As First-Line Treatment For Unresectable Hepatocellular Carcinoma
Portfolio Pulse from Benzinga Newsdesk
Merck and Eisai have received a Complete Response Letter from the FDA for their combination treatment of KEYTRUDA and LENVIMA as a first-line treatment for unresectable hepatocellular carcinoma. This indicates that the FDA has identified issues that need to be addressed before approval.
July 08, 2020 | 10:46 am
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Merck received a Complete Response Letter from the FDA for its KEYTRUDA and LENVIMA combination treatment, indicating regulatory hurdles that need to be addressed before approval.
The Complete Response Letter from the FDA suggests that Merck's combination treatment has not met the necessary requirements for approval, which could delay the product's market entry and impact Merck's stock negatively in the short term.
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