Up­dat­ed: FDA’s safe­ty re­view on CAR-Ts cul­mi­nates in new boxed warn­ings of sec­ondary can­cer

The FDA has told No­var­tis, Gilead, Bris­tol My­ers Squibb and John­son & John­son to add boxed warn­ings on the la­bels of six CAR-T ther­a­pies not­ing the risks of sec­ondary can­cer.

The agency caused a stir in the CAR-T space when it re­vealed the safe­ty re­view in No­vem­ber, which came as a sur­prise to many. Sec­ondary can­cers are a known but un­com­mon risk of many an­ti-can­cer treat­ments; most sci­en­tists, clin­i­cians and com­pa­nies said they re­main rare and are a rel­a­tive­ly small risk fac­tor for an oth­er­wise ef­fec­tive drug class.

Endpoints News

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.