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FDA Approves Tisagenlecleucel for Large B-Cell Lymphoma

Jason M. Broderick @jasoncology
Published: Tuesday, May 01, 2018

Dr Stephen J. Schuster

Stephen J. Schuster, MD
The FDA has approved tisagenlecleucel (Kymriah) for use in adult patients with relapsed/refractory large B-cell lymphoma—including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma—after 2 or more lines of systemic therapy.

In an analysis of 75 infused patients with 3 or more months of follow-up, 60% of patients achieved CR and 21% of patients achieved CR with incomplete blood count recovery following tisagenlecleucel infusion.

References

  1. Schuster SJ, Bishop MR, Tam CS, et al. Primary analysis of Juliet: A global, pivotal, phase 2 trial of CTL019 in adult patients with relapsed or refractory diffuse large B-cell lymphoma. Presented at: ASH Annual Meeting and Exposition; Dec. 9-12, 2017; Atlanta. Abstract 577.
  2. Maude SL, Laetsch TW, Buechner J, et al. Tisagenlecleucel in children and young adults with B-cell lymphoblastic leukemia. N Engl J Med. 2018; 378:439-448.

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