Shares of Chimeric Antigen Receptor (CAR) T cell therapy companies plummeted on November 28, 2023, following an announcement from the U.S. FDA regarding an investigation into reports of patients developing cancer as a potential side effect of their treatments. The FDA’s notice highlighted that both clinical trials and post-market surveillance have yielded reports of T-cell malignancies, including CAR-positive lymphoma, in patients treated with BCMA- or CD19-directed autologous CAR T cell immunotherapies.<\/p>\n\n\n\n
According to the FDA, there have been 19 reported cases of T-cell lymphoma associated with CAR-T treatments. A report from FiercePharma, based on data from investor William Blair, outlines the distribution of these adverse event reports across currently available CAR-T products.<\/p>\n\n\n\n
Summary of FDA Adverse Event Reporting System (FAERS) Data for CAR-T Therapies:<\/strong><\/p>\n\n\n\nTherapy<\/th> Company<\/th> Indications<\/th> Total Reported Cases<\/th> Serious Cases<\/th> Deaths Reported<\/th> T-cell Lymphoma Cases Reported<\/th><\/tr><\/thead> Kymriah<\/td> Novartis (NYSE: NVS<\/a>)<\/td> LBCL, FL, and ALL<\/td> 2,470<\/td> 2,303<\/td> 662<\/td> 7<\/td><\/tr> Yescarta<\/td> Gilead (NASDAQ: GILD<\/a>)<\/td> LBCL and FL<\/td> 3,729<\/td> 3,551<\/td> 746<\/td> 3<\/td><\/tr> Carvykti<\/td> Legend Bio (NASDAQ: LEGN<\/a>) \/ J&J (NYSE: JNJ<\/a>)<\/td> MM<\/td> 408<\/td> 251<\/td> 28<\/td> 1<\/td><\/tr> Breyanzi<\/td> BMS (NYSE: BMY<\/a>)<\/td> LBCL<\/td> 202<\/td> 172<\/td> 38<\/td> 1<\/td><\/tr> Abecma<\/td> BMS (NYSE: BMY<\/a>)<\/td> MM<\/td> 528<\/td> 454<\/td> 60<\/td> 0<\/td><\/tr> Tecartus<\/td> Gilead(NASDAQ: GILD<\/a>)<\/td> MCL and ALL<\/td> 609<\/td> 570<\/td> 136<\/td> 0<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n