Bristol Myers’ CAR-T therapy Breyanzi adds follicular lymphoma to list of approvals

Just two months af­ter earn­ing an­oth­er ap­proval for its block­buster blood can­cer drug Breyanzi, Bris­tol My­ers Squibb can add an ac­cel­er­at­ed ap­proval to the list, this time in the third-line set­ting for adult pa­tients with re­lapsed or re­frac­to­ry fol­lic­u­lar lym­phoma.

The FDA ap­proved the sin­gle-dose, one-time CAR-T ther­a­py for the in­di­ca­tion based on re­sponse rate and du­ra­tion of re­sponse in the TRAN­SCEND-FL tri­al — the over­all re­sponse rate was 95.7% while the com­plete re­sponse rate was 73.4%. Bris­tol My­ers said the re­spons­es were “rapid and durable,” with 80.9% still re­spond­ing at 12 months, and 77.1% re­spond­ing at 18 months.

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.