In a major setback for Eisai and Merck & Co, the FDA has stalled the roll-out of Lenvima as a treatment for earlier untreated liver cancer patients. Big things were expected by Merck & Co when Eisai’s Lenvima was scheduled to be launched in March. Merck has agreed to shell out USD 5.8 billion on half of the liver cancer’s drug sales.

The FDA has stated that the review of the application for the drug would need additional time. A verdict is now expected by the partners by August 24, three months’ after the original decision deadline. The continued review of the application is being supported by Eisai, as the marketing authorization holder, working closely with the FDA.

With the delay in the release of the drug, Bayer has secured a relief with its drug Nexavar dominating the first-line liver cancer field. In a data unveiled last year, Eisai revealed that Lenvima had topped the stalwart in a head-to-head showdown through the posting of a 13.6-month overall survival benefit as compared to a 12.3 survival benefit of Nexavar.

Merck’s decision to partner with Eisai on Lenvima has been a strategic move. Around USD 300 million was handed over by the New Jersey drugmaker upfront and certain rights were procured by paying USD 650 million along with USD 450 million in R&D reimbursement. USD 385 million more was pledged if the partners succeeded in nailing their clinical and regulatory targets. A further USD 3.97 billion was earmarked for pocketing by Eisai if the partners managed to hit their sales marks.