Cytokine Release Syndrome, Neurologic Toxicities, And Secondary Hematological Malignancies

• Cytokine Release Syndrome (CRS), occurred in patients receiving obecabtagene autoleucel. Do not administer obecabtagene autoleucel to patients with active infection or inflammatory disorders. Prior to administering obecabtagene autoleucel , ensure that healthcare providers have immediate access to medications and resuscitative equipment to manage CRS [see Dosage and Administration (2.2, 2.3), Warnings and Precautions (5.1)].
• Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), including fatal or life-threatening reactions, occurred in patients receiving obecabtagene autoleucel, including concurrently with CRS or after CRS resolution. Monitor for neurologic signs and symptoms after treatment with obecabtagene autoleucel. Prior to administering obecabtagene autoleucel, ensure that healthcare providers have immediate access to medications and resuscitative equipment to manage neurologic toxicities. Provide supportive care and/or corticosteroids, as needed [see Dosage and Administration (2.2, 2.3), Warnings and Precautions (5.2)].
• T cell malignancies have occurred following treatment of hematologic malignancies with BCMAand CD19-directed genetically modified autologous T cell immunotherapies [see Warnings and Precautions (5.8)].