Home » Novartis Gets Nod for Second Kymriah Indication
Novartis Gets Nod for Second Kymriah Indication
Drugs Submissions and Approvals
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.