Tisagenlecleucel is approved by FDA for relapsed or refractory follicular lymphoma

June 2022: After two or more lines of systemic therapy, the FDA awarded tisagenlecleucel (Kymriah, Novartis Pharmaceuticals Corporation) expedited approval for adult patients with relapsed or refractory follicular lymphoma (FL).

The approval was based on the results of the ELARA trial (NCT03568461), a multicenter, single-arm, open-label trial evaluating tisagenlecleucel, a CD19-directed chimeric antigen receptor (CAR) T cell therapy, in adult patients who were refractory or relapsed within 6 months after completing two or more lines of systemic therapy (including an anti-CD20 antibody and an alkylating agent) or Tisagenlecleucel was given as a single intravenous infusion after lymphodepleting chemotherapy, with a target dosage of 0.6 to 6.0 x 108 CAR-positive viable T cells.

The overall response rate (ORR) and duration of response (DOR), as established by an independent review committee, were the major efficacy measures. The ORR was 86 percent (95 percent CI: 77, 92) among 90 patients in the primary efficacy analysis, with a CR rate of 68 percent (95 percent CI: 57, 77). The median DOR was not met, with 75% of respondents (95 percent CI: 63, 84) still responding after 9 months. The ORR was 86 percent (95 percent CI: 77, 92) for all patients who had leukapheresis (n=98), with a CR rate of 67 percent (95 percent CI: 57, 76).

Cytokine release syndrome, infection, weariness, musculoskeletal pain, headache, and diarrhoea were the most prevalent adverse effects in patients (>20 percent). 0.6 to 6.0 x 108 CAR-positive viable T cells is the suggested tisagenlecleucel dose.

View full prescribing information for Kymriah.

Susan Hau

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Susan Hau is a distinguished researcher in the field of cancer cell therapy, with a particular focus on T cell-based approaches and cancer vaccines. Her work spans several innovative treatment modalities, including CAR T-cell therapy, TIL (Tumor-Infiltrating Lymphocyte) therapy, and NK (Natural Killer) cell therapy.

Hau's expertise lies in cancer cell biology, where she has made significant contributions to understanding the complex interactions between immune cells and tumors.

Her research aims to enhance the efficacy of immunotherapies by manipulating the tumor microenvironment and exploring novel ways to activate and direct immune responses against cancer cells.

Throughout her career, Hau has collaborated with leading professors and researchers in the field of cancer treatment, both in the United States and China.

These international experiences have broadened her perspective and contributed to her innovative approach to cancer therapy development.

Hau's work is particularly focused on addressing the challenges of treating advanced and metastatic cancers. She has been involved in clinical trials evaluating the safety and efficacy of various immunotherapy approaches, including the promising Gamma Delta T cell therapy.

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• June 16th, 2022