FDA Approves Liso-cel As a Second-line Treatment For Large B-cell Lymphoma

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

louis ochoa

June 28, 2022 | | Reading Time: 4 min

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Large B-cell lymphoma is characterized by rapidly growing tumors in the lymph nodes, spleen, liver, bone marrow, or other organs. Photo: Shutterstock.

Lisocabtagene maraleucel, also known as Smooth-cel (Breyanzi), has been approved by the food administration Y Medicines for the treatment of second line of adult patients with lymphoma relapsed/refractory large B cell (r/r LBCL).

This expanded indication is based on the findings of the pivotal study TRANSFORM phase 3, which showed significant and clinically meaningful improvements with CD19-directed chimeric antigen receptor T-cell immunotherapy 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.

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 of first line therapy, compared with 92 patients receiving standard-of-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 survival progression-free (14.8 vs. 5.7 months; HR, 0.406).

A positive trend was also seen in overall survival (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, including diffuse unspecified LBCL (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:

Disease refractory to first-line chemoimmunotherapy or relapsed 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 transplantation due to comorbidities or age.

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

In February 2022, the FDA granted priority review status to a supplemental biological license application (sBLA) from Bristol Myers Squibbbased on data from the TRANSFORM study, to expand the indication to include use after failure of first-line therapy.

The agent “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 drug development. BMS cell therapy.

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 application “confirms that the submission is complete and begins the EMA’s centralized review procedure,” BMS announced in a June 20, 2022 press release.

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.

Patients should also be monitored for neurological events after treatment with Lyso-cel, and supportive care and/or corticosteroids administered as needed.

consulted source here.

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