Mer­ck, Ei­sai notch full ap­proval for Keytru­da-TKI in­hibitor com­bo in ad­vanced en­dome­tri­al can­cer

Mer­ck PD-1 in­hibitor Keytru­da has been in the hot seat as the FDA ri­fles through its ac­cel­er­at­ed ap­proval pro­gram for drugs that even­tu­al­ly flop con­fir­ma­to­ry stud­ies. But for a Keytru­da com­bo with an Ei­sai TKI in­hibitor in en­dome­tri­al can­cer, that won’t be an is­sue.

The FDA on Thurs­day gave its full ap­proval to a com­bi­na­tion of Keytru­da and TKI in­hibitor Lenvi­ma to treat sec­ond-line or lat­er pa­tients with ad­vanced en­dome­tri­al car­ci­no­ma with­out a ge­net­ic mis­match re­pair de­fi­cien­cy or high mi­crosatel­lite in­sta­bil­i­ty, the drug­mak­ers said Thurs­day.

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