Af­ter 18 years in de­vel­op­ment, As­traZeneca’s CT­LA-4 an­ti­body gets the red car­pet treat­ment at the FDA

Af­ter a decade, a sec­ond CT­LA-4 an­ti­body may fi­nal­ly be on its way to ap­proval.

As­traZeneca an­nounced Mon­day that the FDA had giv­en pri­or­i­ty re­view to treme­li­mum­ab, its long-ges­tat­ing CT­LA-4 an­ti­body, in com­bi­na­tion with the PD-L1 in­hibitor Imfinzi for pa­tients with liv­er can­cer that can’t be treat­ed with surgery.

The Big Phar­ma’s ap­pli­ca­tion is based on a mul­ti-year, 1,324-pa­tient study that showed 30.7% of pa­tients who re­ceived a “prim­ing dose” of treme­li­mum­ab fol­lowed by Imfinzi were alive af­ter three years, com­pared to 20.2% of pa­tients who re­ceived Bay­er’s so­rafenib, the stan­dard of care.

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