Trou­bled by deaths, FDA or­ders Mer­ck to slam the brakes on three Keytru­da stud­ies

A month af­ter Mer­ck flagged a high­er risk of death in two com­bo stud­ies us­ing its flag­ship drug Keytru­da, the FDA has fol­lowed up with a clin­i­cal hold that will slam the brakes on fur­ther treat­ment in three mul­ti­ple myelo­ma tri­als.

Mer­ck said a few weeks ago that it planned to con­tin­ue treat­ment in the two stud­ies – KEYNOTE 183 and KEYNOTE 185 – while paus­ing en­roll­ment of new pa­tients. Those mul­ti­ple myelo­ma tri­als matched Mer­ck’s block­buster ther­a­py with two drugs from Cel­gene, Po­m­a­lyst and its big drug Revlim­id.

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