Wel­come Imfinzi: As­traZeneca crash­es the check­point par­ty late with a green light for dur­val­um­ab

And then there were 5.

The FDA hand­ed out its lat­est ap­proval for a PD-L1 check­point in­hibitor on Mon­day af­ter­noon, giv­ing a green light to As­traZeneca to start sell­ing dur­val­um­ab as Imfinzi as a sec­ond-line ther­a­py for metasta­t­ic urothe­lial car­ci­no­ma.

The reg­u­la­to­ry OK comes in the wake of ap­provals for Mer­ck, Bris­tol-My­ers Squibb, Roche/Genen­tech and Pfiz­er/Mer­ck KGaA. The bi­ol­o­gy of these new check­point drugs is well un­der­stood now, and the FDA is­sued its ap­proval af­ter a rel­a­tive­ly small, sin­gle-arm study.

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