No­var­tis pitch­es two new CAR-T ap­pli­ca­tions to EMA; J&J re­ports pos­i­tive da­ta for lu­pus pro­gram

→ Basel-based No­var­tis $NVS has pushed along a dou­ble-bar­reled ap­pli­ca­tion for its lead­ing CAR-T drug Kym­ri­ah (CTL019). The phar­ma gi­ant has ap­plied to the EMA for ap­provals in B-cell acute lym­phoblas­tic leukemia as well as dif­fuse large B-cell lym­phoma, which will like­ly put it head-to-head with ri­val Gilead’s Yescar­ta. “Since the his­toric FDA ap­proval of Kym­ri­ah, for­mer­ly CTL019, we have launched, man­u­fac­tured and sup­plied this high­ly in­di­vid­u­al­ized im­muno­cel­lu­ar ther­a­py in a com­mer­cial set­ting and the sub­mis­sion to the EMA is a ma­jor step to­ward our goal of de­liv­er­ing it to more crit­i­cal­ly ill can­cer pa­tients around the world,” said Vas Narasimhan, who’s in the process of step­ping up to the CEO post.

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