What is the success rate of Breyanzi?
The success rate of Breyanzi (lisocabtagene maraleucel) varies depending on the condition being treated. Clinical trial data show that complete response rates range from 20% to 73% across different types of lymphoma and leukemia.
Below are clinical trial results for Breyanzi in various conditions, with some patients experiencing partial response to treatment.
Large B-cell lymphoma
Breyanzi was studied in over 250 adults with refractory or relapsed B-cell lymphoma in a multicenter clinical trial. The study showed:
- After treatment with Breyanzi, the complete remission rate was 54%.
- Criteria: 2014 Lugano classification
Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
The complete response rate among patients who took Breyanzi for relapsed or refractory CLL or SLL in a clinical trial called TRANSCEND-CLL was 20%. A total of 65 patients were treated with Breyanzi in the study.
- Criteria: 2018 International Workshop CLL (iwCLL) criteria
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Follicular lymphoma
In the TRANSCEND-FL clinical trial, adults with relapsed or refractory follicular lymphoma who took Breyanzi had a complete response rate of 73.4%. A total of 94 patients that were treated with Breyanzi were included in the final results. In order to be considered to have complete response, patients who did not have a negative bone marrow biopsy between their most recent disease progression and before starting lymphodepleting chemotherapy were required to have a negative bone marrow biopsy.
Mantle cell lymphoma
Out of 68 patients with relapsed or refractory mantle cell lymphoma who were treated with Breyanzi in the TRANSCEND-MCL trial, 67.6% saw a complete response.
- Criteria: 2014 Lugano classification
Individual responses to Breyanzi vary, and partial responses were also observed in these trials. Speak with your healthcare provider to understand how these results may apply to your specific situation.
References
Breyanzi [package insert]. Updated May 2024. Juno Therapeutics, Inc. Accessed August 6, 2024 at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=594bb413-af3b-4b97-afb3-bfe2b174f2ed
U.S. Food and Drug Administration. 2021. FDA Approves New Treatment For Adults With Relapsed Or Refractory Large-B-Cell Lymphoma. Accessed August 6, 2024 at https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-adults-relapsed-or-refractory-large-b-cell-lymphoma
U.S. Food and Drug Administration. 2024. FDA grants accelerated approval to lisocabtagene maraleucel for follicular lymphoma. Accessed August 6, 2024 at https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-lisocabtagene-maraleucel-follicular-lymphoma
U.S. Food and Drug Administration. 2024. FDA approves lisocabtagene maraleucel for relapsed or refractory mantle cell lymphoma. Accessed August 6, 2024 at https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-mantle-cell-lymphoma
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- Breyanzi Information for Consumers
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