Keytruda and Lenvima combination first simultaneous approval spanning Pacific
Merck & Co’s (NYSE: MRK) Keytruda (pembrolizumab) and Eisai’s (TYO: 4523) Lenvima (lenvatinib mesylate) have clocked up two notable milestones.
They are the first combination of an anti-PD-1 therapy and a kinase inhibitor to be approved for advanced endometrial carcinoma in the USA, in what is also a pioneering approval for another reason.
The combination is also the first approval under a new program initiated by the US Food and Drug Administration (FDA) which has meant simultaneous review decisions in the USA, Canada and Australia.
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