(Lymphoma) FDA Approves CAR-T Therapy Breyanzi

• April 19, 2021
• Read time: 1 minute

On February 5, 2021, the U.S. Food and Drug Administration (FDA) approved Bristol Myers Squibb's CAR-T cell therapy Breyanzi (lisocabtagene maraleucel; liso-cel) for patients with relapsed or refractory large B-cell lymphoma. This is the third gene therapy approved by the FDA for diffuse large B-cell lymphoma and certain types of non-Hodgkin's lymphoma.

It is indicated for patients with diffuse large B-cell lymphoma and certain types of non-Hodgkin's lymphoma who have received two or more prior systemic therapies with poor outcomes or relapse after treatment. It is not indicated for patients with CNS lymphoma. The FDA has designated it as an Orphan Drug, Breakthrough Therapy, and Regenerative Medicine Advanced Therapy (RMAT).

Due to potential adverse events such as cytokine release syndrome (CRS) or neurological toxicity, close attention will be paid to whether relevant medical institutions comply with Risk Evaluation and Mitigation Strategy (REMS) requirements. The FDA will evaluate long-term safety and has required manufacturers to conduct post-market observational studies.

Diffuse large B-cell lymphoma is the most common type of non-Hodgkin's lymphoma in adult patients. In the United States, approximately 77,000 new cases of non-Hodgkin's lymphoma are diagnosed annually, of which one-third are diagnosed as diffuse large B-cell lymphoma.

Source: https://www.mixonline.jp/tabid55.html?artid=70614

• Immunotherapy

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