Af­ter a long clin­i­cal odyssey, the FDA tapped this PhI­II an­ti-CCR4 as a ‘break­through’ lym­phoma drug

A day af­ter Ky­owa Hakko Kirin and Ul­tragenyx filed their ap­pli­ca­tion to sell buro­sum­ab, the Japan­ese phar­ma com­pa­ny is fol­low­ing up with the news that it has won the FDA’s break­through ther­a­py des­ig­na­tion for their late-stage lym­phoma drug moga­mulizum­ab.

Ap­proved in Japan over the last few years for sev­er­al in­di­ca­tions, the FDA is en­thu­si­as­tic about the an­ti-CCR4’s chances for My­co­sis Fun­goides and Sézary Syn­drome — two types of cu­ta­neous T-cell lym­phoma — as a sec­ond-line ther­a­py.

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