Eisai and Merck’s fast-growing Lenvima has got a brand-new market—and Bayer’s Nexavar now has some company in the previously untreated liver cancer arena.
On Thursday, the Eisai-Merck team said Lenvima had snagged an FDA approval in first-line hepatocellular carcinoma, the most common type of liver cancer. The approval comes after a three-month delay from the agency, which said in May that it needed more time to review Eisai and Merck’s application.
The new indication will help Lenvima build on the ¥11,859 million ($106 million) in sales it hauled in last quarter with the help of a March front-line HCC approval in Japan. But first, Eisai and Merck will have to poach share from Bayer, which has been running the market for years with Nexavar.
The partners will have clinical trial data on their side; in a head-to-head study between the two drugs, Lenvima just edged out its rival, posting a 13.6-month overall survival benefit compared with Nexavar’s 12.3. But last year’s FDA nod for Bayer’s Stivarga in the second-line setting—which allows the German drugmaker to bill Nexavar-Stivarga as a regimen—could make things tricker.
Meanwhile, the new Lenvima green light is the first in the U.S. since Merck shelled out up to $5.8 billion for half-ownership of the therapy. But the New Jersey pharma giant is expecting many more; it’s testing a combination of Lenvima and its Keytruda with an eye on 11 potential indications across endometrial cancer, non-small cell lung cancer, head and neck cancer and more.