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Months after teaming up on RTK inhibitor Lenvima, Eisai/Merck win new FDA OK in liver cancer

Eisai’s star cancer drug Lenvima — the subject of a recent $300 million pact with Merck — just got the green light from regulators to treat a new indication in liver cancer.

The drug, whose generic name is lenvatinib, was already approved by the FDA in 2015 to treat thyroid cancer, and in 2016 it won approval for renal cell carcinoma. But the med has been lined up to take a shot at several new indications, including this latest OK in hepatocellular carcinoma.

Roger Perlmutter

Lenvatinib belongs to a group of drugs called RTK inhibitors, developed to dial down the mutated proteins that lead to runaway cancer growth. While promising, a big downside to these inhibitors is that patients often develop resistance to the targeted therapies, making progress shortlived. But that makes these drugs good candidates for combination therapies, in hopes that a complementary drug could forestall resistance.

That’s just what Merck decided to try when it signed a $300 million pact with Eisai on this drug earlier this year in a deal that could be worth up to $5 billion in milestones. The duo said it would test lenvatinib in combination with Merck’s cancer darling Keytruda, which is now involved in more than 700 clinical trials.

Eisai and Merck teamed up to develop lenvatinib as a monotherapy and in combination with the checkpoint, with the two sharing development costs. This new approval in hepatocellular carcinoma is the first FDA OK the duo has achieved after inking the deal. And they’re now working together on a pipeline targeting endometrial cancer, non-small cell lung cancer, head and neck cancer, bladder cancer and melanoma, as well as a basket trial targeting multiple cancer types.

“Together with Eisai, we aim to maximize the value of Lenvima for its current indications while jointly pursuing additional approvals in combination with Keytruda across a wide range of cancers,” said Merck R&D chief Roger Perlmutter at the time. “Through this collaboration, we will both broaden our oncology portfolio and have the opportunity to help even more cancer patients around the world.”


Image: Shutterstock


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