柳叶三分钟
柳叶三分钟
木七果c
【FDA green-lights use of a Chinese built cancer therapy】
5 minutes Posted Dec 14, 2019 at 7:43 am.
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In a first, FDA green-lights use of a Chi­nese built can­cer ther­a­py — and more are com­ing
Weeks af­ter Am­gen
took a $2.7 bil­lion stake in BeiGene, the Bei­jing-based biotech has se­cured
its first-ever FDA ap­proval for zanubru­ti­nib, a BTK in­hibitor, months ahead
of sched­ule.
BeiGene’s drug,
brand­ed as Brukin­sa, has se­cured ac­cel­er­at­ed
ap­proval for adult pa­tients with man­tle cell lym­phoma (MCL) — a typ­i­cal­ly
ag­gres­sive, rare, form of blood can­cer — who have re­ceived at least one pri­or
ther­a­py.
The ap­proval is
based on da­ta from pa­tients that were large­ly based out­side of the Unit­ed
States. The main tri­al re­lied up­on in the mar­ket­ing ap­pli­ca­tion is a
sin­gle-arm, 86-pa­tient tri­al, which showe...