Keytru­da wins eighth FDA ap­proval of 2021, mov­ing in­to ad­ju­vant and pe­di­atric melanoma set­tings

Keytru­da made his­to­ry sev­en years ago as the first an­ti-PD-1 ther­a­py ap­proved in the US, win­ning an OK in metasta­t­ic melanoma. The drug has since be­come a megablock­buster, and on Fri­day earned a new ap­proval in the field that got every­thing start­ed.

The FDA rub­ber-stamped Keytru­da’s use as an ad­ju­vant, Mer­ck an­nounced, for mul­ti­ple stages of melanoma in pa­tients old­er than 12 fol­low­ing com­plete re­sec­tion. Pre­vi­ous­ly, Keytru­da was ap­proved in the ad­ju­vant set­ting for adults with Stage III melanoma, but now can be used in adults and ado­les­cents with Stage IIB, Stage IIC and Stage III melanoma as an ad­ju­vant.

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