ADVERTISEMENT
FDA Approves Axicabtagene Ciloleucel for Relapsed or Refractory LBCL
On April 1, 2022, the FDA approved axicabtagene ciloleucel (Yescarta, Kite Pharma Inc.) for the treatment of patients with large B-cell lymphoma (LBCL) that are refractory to first-line chemoimmunotherapy or that have relapsed within 12 months of first-line chemoimmunotherapy.
This approval was based on efficacy data from the open-label, multicenter, phase 3 ZUMA-7 trial involving 359 patients with relapsed or refractory LBCL. Patients were randomized to receive a single infusion of axicabtagene ciloleucel following fludarabine and cyclophosphamide lymphodepleting chemotherapy or a second-line standard therapy consisting of 2 to 3 cycles of chemoimmunotherapy followed by high-dose therapy and autologous hematopoietic stem cell transplantation (autoHSCT).
Overall, event-free survival (EFS) was significantly longer for the axicabtagene ciloleucel arm (HR 0.40; 95% CI, 0.31-0.51; P = <.0001). The estimated 18-month EFS rate was 41.5% (95% CI, 34.2-48.6) for the axicabtagene ciloleucel arm and 17% (95% CI, 11.8-23) in the standard therapy arm. The estimated median EFS was 8.3 months (95% CI, 4.5-15.8) versus 2 months (95% CI, 1.6-2.8), respectively.
Of patients randomized to receive standard therapy, 35% received on-protocol autoHSCT. A lack of response to chemotherapy was the most common cause for not receiving autoHSCT.
The objective response rate was statistically higher in the axicabtagene ciloleucel arm (83%) compared to the standard therapy arm (50%).
The most common (≥30%) non-laboratory adverse reactors include cytokine release syndrome, fever, hypotension, encephalopathy, fatigue, tachycardia, headache, nausea, febrile neutropenia, diarrhea, musculoskeletal pain, infections with pathogen unspecified, chills, and decreased appetite.
Source:
US Food and Drug Administration. FDA approves axicabtagene ciloleucel for second-line treatment of large B-cell lymphoma. April 1, 2022. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-axicabtagene-ciloleucel-second-line-treatment-large-b-cell-lymphoma. Accessed April 4, 2022.
