Mer­ck’s check­point star Keytru­da grabs an­oth­er FDA OK, steer­ing past wreck­age of a Roche dis­as­ter

Mer­ck’s Keytru­da con­tin­ues to make a rapid ad­vance to new ap­provals for ex­pand­ed use. This time the FDA is ap­prov­ing their PD-1 drug for sec­ond-line as well as some first-line cas­es of blad­der can­cer — while Roche’s land­mark OK for the ri­val Tecen­triq (ate­zolizum­ab) in the same in­di­ca­tion has been threat­ened by a stun­ning Phase III fail­ure.

Reg­u­la­tors came up with an ac­cel­er­at­ed ap­proval for Keytru­da for pa­tients whose ad­vanced cas­es of urothe­lial can­cer have pro­gressed af­ter chemother­a­py as well as any front­line pa­tients who aren’t el­i­gi­ble for cis­platin-con­tain­ing chemother­a­py. KEYNOTE-045 pro­vid­ed the da­ta for the sec­ond-line OK, with an ob­jec­tive re­sponse rate of 21% for Keytru­da, close to twice that achieved by chemother­a­py. Those num­bers un­der­score the promise for this field, as well as the need for com­bi­na­tion ther­a­pies that can do much bet­ter. And Mer­ck has hun­dreds of those un­der­way now.

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