
Novartis Says Tisagenlecleucel Met CRR in Early FL Data
Tisagenlecleucel, sold as Kymriah by Novartis, met its primary end point of complete response rate (CRR) in an interim analysis of a phase 2 study for relapsed or refractory follicular lymphoma (FL).
Novartis this week announced that tisagenlecleucel (Kymriah), its chimeric antigen receptor (CAR) T-cell therapy, met its primary end point of complete response rate (CRR) in an interim analysis of a phase 2 study for relapsed or refractory (r/r)
The company said results from
Tisagenlecleucel is currently indicated for r/r pediatric and young adult acute lymphoblastic leukemia (ALL) as well as r/r adult
Novartis plans to file for FDA approval for an FL indication in 2021.
“We are pleased that Kymriah is showing meaningful results and may provide a potentially definitive treatment option for patients with relapsed and refractory follicular lymphoma,” John Tsai, MD, head of Global Drug Development and the company’s chief medical officer,
Last week, another drug was approved for DLBCL, with the FDA clearing tafasitamab, to be sold as Monjuvi by MorphoSys and Incyte. Tafasitamab is a humanized Fc-modified cytolytic CD19 monoclonal antibody being studied in several B-cell malignancies.
FL is a typically slow-growing or indolent form of non-Hodgkin lymphoma (NHL) that serves as the most common indolent lymphoma, accounting for approximately 20% of all NHL cases. While patients with FL can live for many years, the condition is generally not curable and is a chronic disease.
When in
Last month, the FDA approved the third CAR T-cell therapy, Kite Pharma’s
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