Another Breakthrough Therapy designation for Lenvima and Keytruda

1 August 2018

Japanese drugmaker Eisai (TYO: 4523) and its American development partner Merck & Co (NYSE: MRK) have won Breakthrough Therapy designation for a combo of Lenvima (lenvatinib) and Keytruda (pembrolizumab).

The two firms are working together after Merck paid $300 million, with the potential for more than $5 billion in milestones, for certain development and commercialization rights in respect of Lenvima, an oral receptor tyrosine kinase (RTK) inhibitor.

The US Food and Drug Administration granted the status, which affords closer cooperation with the aim of expediting the review process, with respect to a certain indication of endometrial carcinoma (EC), in the second-line setting.

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