Novartis Gets Nod for Second Kymriah Indication

The FDA approved an additional indication for Novartis’ Kymriah (tisagenlecleucel) for relapsed or refractory large B-cell lymphoma.

The indication specifically applies after two or more lines of systemic therapy and includes diffuse large B-cell lymphoma, the most common form of non-Hodgkins lymphoma.

The drug was approved last August for treatment of patients up to 25 years old with B-cell precursor acute lymphoblastic leukemia. The second indication makes Kymriah the only CAR-T cell therapy cleared for two indications.