FDA qui­et­ly turns Keytru­da ac­cel­er­at­ed ap­proval for less-fre­quent dos­ing in­to full ap­proval

Mer­ck’s an­ti-PD-1 an­ti­body block­buster Keytru­da had a less-fre­quent dos­ing reg­i­men pre­vi­ous­ly cleared un­der an ac­cel­er­at­ed ap­proval con­vert­ed in­to full ap­provals on Dec. 16.

The ac­cel­er­at­ed ap­proval was orig­i­nal­ly grant­ed in 2020, and al­lowed for dos­ing of pa­tients once every six weeks with 400 mg of the drug, as op­posed to 200 mg every three weeks. The us­es be­ing con­vert­ed to full ap­proval in­clude:

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