Second FDA approval for Novartis’ Kymriah

Novartis has received approval from the FDA for its CAR-T therapy Kymirah for the treatment of adults with relapsed or refractory large B-cell lymphoma. Kymriah is the only chimeric antigen receptor T cell therapy (CAR-T) to received approval from the FDA for two separate indications in non-Hodgkin lymphoma and B-cell precursor acute lymphoblastic leukemia.

“The goal of Kymriah is to provide physicians with a therapy that has demonstrated durable response rates in relapsed or refractory DLBCL patients, a patient population that has endured multiple rounds of chemotherapy with many having experienced unsuccessful stem cell transplants,” said Stephen J. Schuster, MD, the Robert and Margarita Louis-Dreyfus Professor in Chronic Lymphocytic Leukemia and Lymphoma Clinical Care “With this approval, physicians now have a meaningful therapeutic option that can achieve and maintain a sustained response without stem cell transplant along with a consistent safety profile.”