The application is based on data showing that lisocabtagene provides clinically meaningful and statistically significant improvement for those with relapsed or refractory large B-cell lymphoma.
The FDA has accepted a supplemental biologics license application (sBLA) for lisocabtagene maraleucel (Breyanzi, Bristol Myers Squibb), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, to expand its indication to include earlier use of the drug for the treatment of individuals with relapsed or refractory large B-cell lymphoma (LBCL) after first-line therapy is not successful.
The FDA has granted the application priority review and assigned a Prescription Drug User Fee Act goal date of June 24, 2022.
“Breyanzi as a differentiated CD19-directed CAR T cell therapy has already proven to be an important treatment option for patients with relapsed or refractory large B-cell lymphoma after 2 or more lines of systemic therapy and now has the potential to be a new standard of care for patients after failure of first-line therapy, offering significantly improved outcomes beyond the current mainstay of care,” Anne Kerber, senior vice president of Cell Therapy Development at Bristol Myers Squibb, said in a statement. “This acceptance from the FDA brings us 1 step closer to delivering a practice-changing treatment for primary refractory or relapsed large B-cell lymphoma, making Breyanzi available to more patients in need, and underscores the advancements we’re making in cell therapy research to transform the lives of patients with difficult-to-treat blood cancers, including lymphoma.”.
The sBLA is based on results from the phase 3 TRANSFORM trial, which was a global multicenter, randomized study evaluating lisocabtagene maraleucel as a second-line treatment compared with the standard-of-care treatment.
The second-line standard-of-care treatment consists of of salvage chemotherapy, followed by high-dose chemotherapy plus autologous hematopoietic stem cell transplant.
The study results showed that lisocabtagene maraleucel provided clinically meaningful and statistically significant improvements in complete responses, event-free survival, and progression-free survival.
Additionally, there was a positive trend in the overall survival rate of individuals with LBCL whose disease was primary refractory or relapsed within 12 months after first-line therapy compared with the standard of care.
Serious adverse reactions occurred in about 46% of individuals, and these included cytokine release syndrome (CRS), delirium, dizziness, encephalopathy, fever, hypotension, pneumonia, and sepsis, according to the statement.
Fatal adverse reactions occurred in 4% of individuals.
The results were presented at the American Society of Hematology Annual Meeting and Exposition in December 2021.
The FDA has already approved lisocabtagene maraleucel for the treatment of adult individuals with relapsed or refractory LBCL after 2 or more lines of systemic therapy, including diffuse large B-cell lymphoma not otherwise specified, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.
US Food and Drug Administration (FDA) accepts for priority review Bristol Myers Squibb’s supplemental biologics license application for Breyanzi (lisocabtagene maraleucel) as a second-line therapy for relapsed or refractory large B-cell lymphoma. Bristol Myers Squibb. News release. February 17, 2022. Accessed February 17, 2022. https://news.bms.com/news/corporate-financial/2022/U.S.-Food-and-Drug-Administration-FDA-Accepts-for-Priority-Review-Bristol-Myers-Squibbs-Supplemental-Biologics-License-Application-for-Breyanzi-lisocabtagene-maraleucel-as-a-Second-Line-Therapy-for-Relapsed-or-Refractory-Large-B-cell-Lymphoma/default.aspx