Astel­las hit with CRL for Claudin 18.2 drug due to third-par­ty man­u­fac­tur­ing is­sues

The FDA hand­ed Astel­las a com­plete re­sponse let­ter for its CLDN18.2 drug zol­be­tux­imab in gas­tric and gas­troe­sophageal junc­tion can­cers af­ter find­ing “un­re­solved de­fi­cien­cies” at a third-par­ty man­u­fac­tur­er.

The Jan. 4 CRL came a week be­fore the orig­i­nal PDU­FA date of Jan. 12. An agency in­spec­tion re­vealed is­sues at the zol­be­tux­imab man­u­fac­tur­ing fa­cil­i­ty, Astel­las said on Mon­day. These man­u­fac­tur­ing is­sues are not caus­ing any safe­ty con­cerns, ef­fi­ca­cy da­ta is­sues and no ad­di­tion­al stud­ies are re­quired, the com­pa­ny added.

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