FDA instructs drugmakers to add T cell malignancy risk info to CAR-T labels

In a series of letters sent to Bristol-Myers Squibb (BMY), Novartis Pharmaceuticals (NVS), Janssen Research & Development (JNJ) and Kite Pharma (GILD), the FDA stated in part: “(W)e have become aware of the risk of T cell malignancies, with serious outcomes, including hospitalization and death, following treatment with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies. FDA identified postmarketing adverse event and clinical trial reports describing occurrence of mature T cell malignancies, including CAR-positive tumors, following treatment with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies… We consider this information to be ‘new safety information’ as defined in section 505-1(b)(3) of the FDCA. Furthermore, we consider the serious risk of T cell malignancy to be applicable to all BCMA- and CD19-directed genetically modified autologous T cell immunotherapies… we have determined that the new safety information should be included in the labeling for all BCMA- and CD19-directed genetically modified autologous T cell immunotherapies.” Shares of Cabaletta Bio (CABA) are down 7% in after-hours trading following the FDA safety labeling changes communications. Previously, Gracell (GRCL) shares had also fallen after the FDA had said that it was investigating CAR T toxicity.