EU reg­u­la­to­ry com­mit­tee rec­om­mends 8 new drugs for ap­proval, in­clud­ing Bris­tol My­er­s' BC­MA CAR-T

At its June meet­ing, the Eu­ro­pean Med­i­cine Agency’s Com­mit­tee for Med­i­c­i­nal Prod­ucts for Hu­man Use rec­om­mend­ed eight new drugs for ap­proval, bring­ing this year’s count to 50 pos­i­tive opin­ions.

While the Eu­ro­pean Com­mis­sion doesn’t need to fol­low the CHMP’s rec­om­men­da­tions, it typ­i­cal­ly does. Here are the drugs that got the com­mit­tee’s green light this month:

Abec­ma 

A few months af­ter be­com­ing the first mar­ket­ed BC­MA CAR-T ther­a­py, blue­bird and Bris­tol My­ers Squibb’s Abec­ma (al­so known as ide-cel) has snagged a CHMP rec­om­men­da­tion for con­di­tion­al mar­ket­ing ap­proval in re­lapsed or re­frac­to­ry mul­ti­ple myelo­ma. The com­mit­tee rec­om­mends the drug as a fourth-line ther­a­py, af­ter pa­tients have tried an im­munomod­u­la­to­ry agent, a pro­tea­some in­hibitor and an an­ti-CD38 an­ti­body.

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.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER