NOW APPROVED in adults with relapsed / refractory ( r / r ) diffuse large B-cell lymphoma ( DLBCL )*
The first FDA-approved CAR-T cell therapy now has 2 indications
NOW APPROVED in adults with relapsed / refractory ( r / r ) diffuse large B-cell lymphoma ( DLBCL )*
KYMRIAH ® ( tisagenlecleucel ) is also THE ONLY CAR-T cell therapy approved for the treatment of patients up to 25 years of age with r / r B-cell acute lymphoblastic leukemia ( ALL )†
See full indications below .
Visit KYMRIAH-hcp . com or call KYMRIAH CARES™ at 1-844-4KYMRIAH ( 1-844-459-6742 ) to learn more about KYMRIAH , including treatment center locations , coverage support , and patient assistance .
INDICATIONS KYMRIAH is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of :
• † Patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia ( ALL ) that is refractory or in second or later relapse
• * Adult patients with relapsed or refractory ( r / r ) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma ( DLBCL ) not otherwise specified , high-grade B-cell lymphoma , and DLBCL arising from follicular lymphoma
Limitation of Use : KYMRIAH is not indicated for treatment of patients with primary central nervous system lymphoma .
IMPORTANT SAFETY INFORMATION FOR KYMRIAH ® ( tisagenlecleucel ) WARNING : CYTOKINE RELEASE SYNDROME AND NEUROLOGICAL TOXICITIES
• Cytokine Release Syndrome ( CRS ), including fatal or life-threatening reactions , occurred in patients receiving KYMRIAH . Do not administer KYMRIAH to patients with active infection or inflammatory disorders . Treat severe or life-threatening CRS with tocilizumab , or tocilizumab and corticosteroids
• Neurological toxicities , which may be severe or life-threatening , can occur following treatment with KYMRIAH , including concurrently with CRS . Monitor for neurological events after treatment with KYMRIAH . Provide supportive care as needed
• KYMRIAH is available only through a restricted program under a Risk Evaluation and Mitigation Strategy ( REMS ) called the KYMRIAH REMS
Please see additional Important Safety Information and Brief Summary of Prescribing Information for KYMRIAH , including Boxed WARNING , on the following pages .