FDA ac­cepts an­oth­er sBLA for Mer­ck­'s Keytru­da, fol­low­ing Imfinzi in bil­iary tract can­cer

Mer­ck an­nounced Thurs­day morn­ing that the FDA has ac­cept­ed an sBLA for its sales king­pin and an­ti-PD-1 ther­a­py Keytru­da, set­ting a de­ci­sion for ear­ly next year as the phar­ma at­tempts to fol­low As­traZeneca’s Imfinzi in­to yet an­oth­er in­di­ca­tion.

The ap­pli­ca­tion aims to get Keytru­da ap­proved as a com­bi­na­tion treat­ment along­side chemother­a­pies gem­c­itabine and cis­platin in pa­tients with lo­cal­ly ad­vanced un­re­sectable or metasta­t­ic bil­iary tract can­cer and is based on a Phase III tri­al called KEYNOTE-966, where over­all sur­vival was high­er in the treat­ment group by a sta­tis­ti­cal­ly sig­nif­i­cant mar­gin.

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