FDA approves Liso-cel as a treatment for large B-cell lymphoma

FDA approves Liso-cel as a treatment for large B-cell lymphoma
  • Liso-cel (Breyanzi), has been approved by the Food and Drug Administration.
  • Liso-cel is not indicated for the treatment of patients with primary lymphoma of the central nervous system.
  • The warning states that lisa-cel should not be given to patients with active infection or inflammatory disorders, and that severe or life-threatening CRS should be treated with tocilizumab with or without corticosteroids.

Lisocabtagene maraleucel, also known as Liso-cel (Breyanzi), has been approved by the Food and Drug Administration for the second-line treatment of adult patients with lymphoma of large B cells relapsed or refractory (r/r LBCL).

This expanded indication is based on findings from the pivotal Phase 3 TRANSFORM study, which showed significant and clinically significant improvements with T-cell immunotherapy CD19-targeted chimeric antigen receptor compared with salvage chemotherapy followed by high-dose chemotherapy plus autologous stem cell transplantation. The last course of treatment had been the standard of care for more than 2 decades.

A positive trend in overall survival was observed

Data from the global, randomized, multicenter TRANSFORM study, as reported in December 2021 at the annual meeting of the American Society of Hematologyshowed that second-line treatment with lisa-cel in 92 patients with LBCL r/r within 12 months after the first.

The line therapy, compared with 92 patients who received the standard Care Therapy, was associated with a highly statistically and clinically significant improvement in event-free survival (10.1 vs. 2.3 months; hazard ratio, 0.349), complete response rate (66% vs. 39%) and progression-free survival (14.8 vs. 5.7 months; HR, 0.406).

A positive trend in overall survival was also observed (HR, 0.509 with a median follow-up of 6.2 months). No new safety signals for lisa-cel were detected in the second-line environment.

Liso-cel was initially approved in February 2021 for the treatment of adults with LBCL

Liso-cel was initially approved in February 2021 for the treatment of adults with LBCLincluding diffuse LBCL not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B lymphoma, which have:

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disease refractory to chemoimmunotherapy first-line or relapse within 12 months after first-line chemoimmunotherapy.

disease refractory to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplant due to comorbidities or age.

Liso-cel is not indicated for the treatment of patients with primary lymphoma of the central nervous system.

The FDA granted priority review status to a Supplemental Biological License Application (sBLA)

In February 2022, the FDA granted priority review status to a Supplemental Biologics License Application (sBLA) from Bristol-Myers Squibb, based on data from the TRANSFORM study, to expand the indication to include use after therapy failure From first line.

The agent “It now has the potential to be a new standard of care for patients after failure of first-line therapy, offering significantly better outcomes beyond the current mainstay of care,” said Anne Kerber, senior vice president of cell therapy development at BMS.

The European Medicines Agency has also validated a type II variation request for the extension of the indication for lisa-cel in this context. Validation of the request “confirms that the submission is complete and begins the EMA centralized review procedure”BMS announced in a press release dated June 20, 2022.

Liso-cel, which has been available only through a restricted program under a risk assessment and mitigation strategy, includes a boxed warning about the risk of cytokine release syndrome (CRS) and neurological toxicities.

The warning states that lisa-cel should not be given to patients with active infection or inflammatory disorders, and that severe or life-threatening CRS should be treated with tocilizumab with or without corticosteroids.

You should also monitor the patients to detect neurological events after treatment with lisa-cel, and supportive care and/or corticosteroids should be given as needed.

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