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The FDA has approved lisocabtagene maraleucel (Breyanzi, Bristol Myers Squibb) for relapsed or refractory marginal zone lymphoma (MZL) in adults after at least two prior lines of systemic therapy.
Lisocabtagene maraleucel (liso–cel) is now the only CD19-directed chimeric antigen receptor (CAR) T–cell therapy approved for MZL. The approval marks liso-cel’s fifth indication, the most of any CD19-directed CAR T–cell therapy, BMS said in a press release.
Prior approvals are also in the relapsed or refractory setting and include large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, and chronic lymphocytic leukemia/small lymphocytic lymphoma.
MZL is a slow-growing subtype of non-Hodgkin lymphoma (NHL), accounting for about 7% of all NHL cases and typically diagnosed in older adults. Prognosis is generally favorable, but in patients who relapse or become refractory, NHL can transform into diffuse large B-cell lymphoma.
Basis for Approval
Liso-cel’s new approval was based on the MZL cohort of the single arm TRANSFORM FL trial, which included 66 patients in the third or later lines; 95.5% responded to the one-time treatment, with 62.1% having a complete response. Responses were durable in 90.1% of patients at 2 years, according to the BMS press release.
In terms of safety, 76% of MZL patients developed cytokine release syndrome, which was grade 3 or worse in 4.5%. Nervous system disorders included headache (21%, grade ≥ 3 in 1.5%), encephalopathy (21%, grade ≥ 3 in 1.5%), tremor (21%), dizziness (16%), and aphasia (10%).
Labeling also warns of hypersensitivity reactions, serious infections, prolonged cytopenias, hypogammaglobulinemia, and secondary malignancies.
Cost of Treatment
One-time treatment costs $567,237.18, according to drugs.com. BMS noted liso-cel is broadly covered by commercial and government insurance programs.
M. Alexander Otto is a physician assistant with a master’s degree in medical science and a journalism degree from Newhouse. He is an award–winning medical journalist who worked for several major news outlets before joining this news organization. Alex is also an MIT Knight Science Journalism fellow. Email: aotto@mdedge.com
A version of this article first appeared on Medscape.com.
The FDA has approved lisocabtagene maraleucel (Breyanzi, Bristol Myers Squibb) for relapsed or refractory marginal zone lymphoma (MZL) in adults after at least two prior lines of systemic therapy.
Lisocabtagene maraleucel (liso–cel) is now the only CD19-directed chimeric antigen receptor (CAR) T–cell therapy approved for MZL. The approval marks liso-cel’s fifth indication, the most of any CD19-directed CAR T–cell therapy, BMS said in a press release.
Prior approvals are also in the relapsed or refractory setting and include large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, and chronic lymphocytic leukemia/small lymphocytic lymphoma.
MZL is a slow-growing subtype of non-Hodgkin lymphoma (NHL), accounting for about 7% of all NHL cases and typically diagnosed in older adults. Prognosis is generally favorable, but in patients who relapse or become refractory, NHL can transform into diffuse large B-cell lymphoma.
Basis for Approval
Liso-cel’s new approval was based on the MZL cohort of the single arm TRANSFORM FL trial, which included 66 patients in the third or later lines; 95.5% responded to the one-time treatment, with 62.1% having a complete response. Responses were durable in 90.1% of patients at 2 years, according to the BMS press release.
In terms of safety, 76% of MZL patients developed cytokine release syndrome, which was grade 3 or worse in 4.5%. Nervous system disorders included headache (21%, grade ≥ 3 in 1.5%), encephalopathy (21%, grade ≥ 3 in 1.5%), tremor (21%), dizziness (16%), and aphasia (10%).
Labeling also warns of hypersensitivity reactions, serious infections, prolonged cytopenias, hypogammaglobulinemia, and secondary malignancies.
Cost of Treatment
One-time treatment costs $567,237.18, according to drugs.com. BMS noted liso-cel is broadly covered by commercial and government insurance programs.
M. Alexander Otto is a physician assistant with a master’s degree in medical science and a journalism degree from Newhouse. He is an award–winning medical journalist who worked for several major news outlets before joining this news organization. Alex is also an MIT Knight Science Journalism fellow. Email: aotto@mdedge.com
A version of this article first appeared on Medscape.com.
The FDA has approved lisocabtagene maraleucel (Breyanzi, Bristol Myers Squibb) for relapsed or refractory marginal zone lymphoma (MZL) in adults after at least two prior lines of systemic therapy.
Lisocabtagene maraleucel (liso–cel) is now the only CD19-directed chimeric antigen receptor (CAR) T–cell therapy approved for MZL. The approval marks liso-cel’s fifth indication, the most of any CD19-directed CAR T–cell therapy, BMS said in a press release.
Prior approvals are also in the relapsed or refractory setting and include large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, and chronic lymphocytic leukemia/small lymphocytic lymphoma.
MZL is a slow-growing subtype of non-Hodgkin lymphoma (NHL), accounting for about 7% of all NHL cases and typically diagnosed in older adults. Prognosis is generally favorable, but in patients who relapse or become refractory, NHL can transform into diffuse large B-cell lymphoma.
Basis for Approval
Liso-cel’s new approval was based on the MZL cohort of the single arm TRANSFORM FL trial, which included 66 patients in the third or later lines; 95.5% responded to the one-time treatment, with 62.1% having a complete response. Responses were durable in 90.1% of patients at 2 years, according to the BMS press release.
In terms of safety, 76% of MZL patients developed cytokine release syndrome, which was grade 3 or worse in 4.5%. Nervous system disorders included headache (21%, grade ≥ 3 in 1.5%), encephalopathy (21%, grade ≥ 3 in 1.5%), tremor (21%), dizziness (16%), and aphasia (10%).
Labeling also warns of hypersensitivity reactions, serious infections, prolonged cytopenias, hypogammaglobulinemia, and secondary malignancies.
Cost of Treatment
One-time treatment costs $567,237.18, according to drugs.com. BMS noted liso-cel is broadly covered by commercial and government insurance programs.
M. Alexander Otto is a physician assistant with a master’s degree in medical science and a journalism degree from Newhouse. He is an award–winning medical journalist who worked for several major news outlets before joining this news organization. Alex is also an MIT Knight Science Journalism fellow. Email: aotto@mdedge.com
A version of this article first appeared on Medscape.com.