FDA grants full ap­proval to Keytru­da in tu­mor-ag­nos­tic set­ting; Can­del paus­es tri­al en­roll­ment

In a first, Mer­ck has se­cured a full ap­proval for Keytru­da in a tu­mor ag­nos­tic set­ting — as a treat­ment for any un­re­sectable or metasta­t­ic sol­id tu­mors that are clas­si­fied as mi­crosatel­lite in­sta­bil­i­ty-high (MSI-H) or mis­match re­pair de­fi­cient (dMMR).

The FDA grant­ed Keytru­da ac­cel­er­at­ed ap­proval in this in­di­ca­tion in 2017, and GSK’s Jem­per­li fol­lowed suit in 2021. But now it’s con­vert­ed to a full ap­proval for Keytru­da. Be­fore pre­scrib­ing, doc­tors would have to make sure pa­tients car­ry this bio­mark­er, us­ing an FDA-ap­proved test.

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