Dr. Flinn on FDA Approval of Tisagenlecleucel in DLBCL

Ian W. Flinn, MD, PhD, director of Lymphoma Research, principal investigator, Sarah Cannon Research Institute, discusses the FDA approval of the chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel (Kymriah) for use in adult patients with relapsed/refractory large B-cell lymphoma—including diffuse large B-cell lymphoma (DLBCL).

The approval is based on the phase II JULIET study, in which the CD19-directed CAR T-cell therapy reached an overall response rate of 50% (95% CI, 38%-62%) in adult patients with relapsed/refractory DLBCL. The complete response rate was 32% and the partial response rate was 18%. The median duration of response had not been reached.

This approval also includes patients with high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma after 2 or more lines of systemic therapy. At the data cutoff, 147 patients were enrolled, 99 of whom were infused with a single dose of tisagenlecleucel transduced cells (median, 3.1 x 10⁸cells; range, 0.1-6.0 x 10⁸).