FDA grants second approval to tisagenlecleucel (Kymriah) for the treatment of R/R large B-cell lymphoma

On 01 May 2018, it was announced in a press release that the US Food and Drug Administration (FDA) approved the Novartis CAR-T therapy, tisagenlecleucel (Kymriah), as an intravenous suspension for its second indication for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma and transformed follicular lymphoma (tFL). This therapy is targeted to patients who do not respond to second or later line therapy, including autologous stem cell transplantation. Kymriah is not indicated for the treatment of patients with primary central nervous system lymphoma (PCNSL).

This CAR-T therapy received its first FDA approval in August 2017 for the treatment of pediatric and young adult R/R acute lymphoblastic leukemia (ALL) patients who do not respond to second or later line treatment.

Stephen Schuster, Professor at Penn Medicine and Director of the Lymphoma Program at the Abramson Cancer Center commented that "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."