More FDA support for Lenvima plus Keytruda combination
A new combination therapy for liver cancer has been granted Breakthrough Therapy designation (BTD) by the US Food and Drug Administration, unlocking expedited development and review by the US regulator.
The FDA has granted the designation for a combination of Lenvima (lenvatinib), from Eisai (TYO: 4523) - which is marketed as Kisplyx in Europe - and Keytruda (pembrolizumab), from Merck & Co (NYSE: MRK).
It is the third BTD awarded to the drugmakers for this combination, which marries Eisai’s orally available kinase inhibitor with the world’s leading anti-PD-1 therapy.
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