Immuno-Oncology Resource Center

Immuno-Oncology Resource Center

February 05, 2021
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FDA approves Breyanzi, new CAR T-cell therapy for advanced large B-cell lymphoma

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The FDA granted accelerated approval to lisocabtagene maraleucel for adults with relapsed or refractory large B-cell lymphoma who received at least two prior therapies.

The chimeric antigen receptor T-cell therapy is not indicated for patients with primary central nervous system lymphoma, according to an FDA-issued press release.

FDA Approval
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Lisocabtagene maraleucel (Breyanzi, Bristol Myers Squibb) is a gene edited, autologous CAR T-cell therapy that targets the CD19 antigen expressed on the surface of cancer cells.

Caron A. Jacobson, MD
Caron Jacobson

“CAR T cell therapy continues to make very important progress, and the FDA’s approval of this therapy for relapsed or refractory large B-cell lymphoma offers hope and optimism to a group of patients whose other treatments have failed them,” Caron Jacobson, MD, MMSc, assistant professor of medicine at Harvard Medical School and medical director of the immune effector cell therapy program at Dana-Farber Cancer Institute, told Healio. “As clinicians, our goal to help patients and improve their quality of life, and I’m encouraged to be able to provide another option for patients with no other effective treatments.”

Lisocabtagene maraleucel is the fourth CAR T-cell therapy approved by the FDA, and the third for large B-cell lymphoma.

The FDA previously approved axicabtagene ciloleucel (Yescarta; Kite Pharma/Gilead) for treatment of adults with relapsed or refractory large B-cell lymphoma and tisagenlecleucel (Kymriah, Novartis) for certain patients with diffuse large B-cell lymphoma.

The FDA had twice delayed its decision on lisocabtagene maraleucel, most recently because of an inability to conduct a manufacturing site inspection due to COVID-19-related travel restrictions.

Peter Marks, MD, PhD
Peter Marks

“[This] approval represents another milestone in the rapidly progressing field of gene therapy by providing an additional treatment option for adults with certain types of cancer affecting the blood, bone marrow and lymph nodes,” Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, said in the release. “Gene and cell therapies have evolved from promising concepts to practical cancer treatment regimens.”

The FDA based approval of lisocabtagene maraleucel on data from the TRANSCEND-NHL-001 trial of 269 patients (median age, 63 years; interquartile range, 54-70; 65% men) with relapsed or refractory large B-cell lymphoma.

The efficacy analysis, which included 256 patients, showed an objective response rate of 73% (95% CI, 66.8-78) and a complete response rate of 53% (95% CI, 46.8-59.4) after one infusion of lisocabtagene maraleucel. Fifty-eight percent of patients remained alive 1 year after therapy.

The safety analysis showed 42% of patients experienced cytokine release syndrome (CRS), but few cases (2%) were grade 3 or greater. In addition, 30% of patients had symptoms of neurotoxicity.

Lisocabtagene maraleucel will include a boxed warning that outlines risks for CRS and neurotoxicity associated with CAR T-cell therapy. The FDA also is requiring the manufacturer to conduct a post-marketing observational study of patients treated with lisocabtagene maraleucel to comply with its Risk Evaluation and Mitigation Strategy monitoring program.