FDA sends letter to Novartis over ‘significant’ Kymriah manufacturing safety concerns

The FDA on Tues­day re­leased a new un­ti­tled let­ter, sent in Au­gust to No­var­tis, af­ter the agency’s in­spec­tors found new and sig­nif­i­cant is­sues with how Kym­ri­ah, the first-ever FDA-ap­proved CAR-T cell ther­a­py, is made at the com­pa­ny’s Mor­ris Plains, NJ, site.

While the FDA said it al­ready is­sued a Form 483 out­lin­ing some of its ear­ly thoughts on the late 2022 in­spec­tion, and re­ceived re­spons­es from No­var­tis, the agency says it’s now iden­ti­fied “ad­di­tion­al sig­nif­i­cant de­vi­a­tions” up­on fur­ther re­view of the in­for­ma­tion col­lect­ed dur­ing that in­spec­tion.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.