According to a press release from Novartis, the US Food and Drug Administration (FDA) granted priority review to the company’s Supplemental Biologics License Application (sBLA) for tisagenlecleucel (Kymriah®) in the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after 2 prior lines of treatment.1

Tisagenlecleucel is an anti-CD19 chimeric antigen receptor (CAR) T-cell therapy that was first approved by the FDA for the treatment of R/R B-cell acute lymphoblastic leukemia (B-ALL); it was the first CAR-T therapy approved in the US.2

The regulatory filing is supported by results from the pivotal ELARA trial, which demonstrated that treatment with tisagenlecleucel produced high and robust complete response rates with a favorable safety profile in adult patients with R/R FL.1,3


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The company also announced that the European Medicines Agency accepted the company’s Type II Variation for the use of tisagenlecleucel in adult patients with R/R FL. The European Commission (EC) granted tisagenlecleucel designation as an orphan medicine for FL earlier this year.1

In both the US and European Union, tisagenlecleucel is indicated for the treatment of R/R B-ALL in children and young adults and R/R diffuse large B-cell lymphoma in adults.1,4

In the press release, Jeff Legos, Executive Vice President, Global Head of Oncology & Hematology Development, Novartis, said, “This is an important milestone in our mission to bring Kymriah to adult patients with relapsed or refractory follicular lymphoma. Receiving orphan drug designation from the EC as well as priority review from the FDA underscores the unmet need and urgency for these patients. With Kymriah demonstrating impressive results in the ELARA trial, we are hopeful that we can offer a unique and potentially definitive treatment that minimizes the burden.”1

References

  1. Novartis receives priority review by US FDA and filing acceptance by EMA for Kymriah® to treat patients with relapsed or refractory follicular lymphoma. Basel, Switzerland: Novartis; October 27, 2021.
  2. Liu Y, Chen X, Han W, Zhang Y. Tisagenlecleucel, an approved anti-CD19 chimeric antigen receptor T-cell therapy for the treatment of leukemia. Drugs Today (Barc). 2017;53(11):597-608. doi:10.1358/dot.2017.53.11.2725754
  3. Fowler NH, Dickinson M, Dreyling M, et al. Efficacy and safety of tisagenlecleucel in adult patients with relapsed/refractory follicular lymphoma: interim analysis of the phase 2 Elara trialBlood 2020; 136(suppl 1):1-3. doi: https://doi.org/10.1182/blood-2020-138983
  4. European Medicines Agency. Kymriah. Updated October 29, 2021. Accessed November 2, 2021. https://www.ema.europa.eu/en/medicines/human/EPAR/kymriah