10th of February 2021

FDA approves Breyanzi®, a new CAR-T cell therapy drug.

Fourth approved CAR-T cell therapy soon to be available in Europe? 


Bristol Myers Squibb (NYSE: BMY) announced on 5 February 2021 that the U.S. Food and Drug Administration (FDA) approved Breyanzi® (lisocabtagene maraleucel or liso-cel) 1.

The product, now marketed under the brand name Breyanzi®, is a CD19-targeted, genetically modified autologous T-cell immunotherapy for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after two or more lines of systemic therapy. It can also be used to treat patients with diffuse large B-cell lymphoma (DLBCL), including those arising from indolent lymphoma, as well as patients with high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma and grade 3B follicular lymphoma. In addition, exclusion is indicated for the treatment of patients with primary central nervous system lymphoma 2,3.

Originally, liso-cel was supposed to be approved by 16 November 2020, but the pandemic has blown up this schedule. Due to the COVID-19 pandemic, FDA inspectors were not allowed to travel and this caused delays in the approval of a third-party manufacturing facility in Texas, Bristol Myers Squibb announced in November 2020.

Now, however, the time has come!

Breyanzi®, a CAR T-cell therapy targeting CD19, with a 4-1BB costimulatory domain will be administered with a defined 50/50 ratio of CD4+/CD8+ T-cells. According to product developer Juno, the defined T-cell ratio should allow for more controllable and safer therapy. The 4-1BB component enhances the expansion and persistence of Breyanzi®. A single dose of Breyanzi® contains 50 to 110 x 106 CAR-positive viable T cells.

The FDA approval of Breyanzi® is based on data from the TRANSCEND NHL001(017001) trial, in which 268 patients with R/R LBCL received Breyanzi®. In the trial, Breyanzi® was administered in both the inpatient and outpatient settings 4.

To support broad patient access, Bristol Myers Squibb plans to roll out Breyanzi® through an extensive network of treatment centres. These will be audited and certified according to the Risk Evaluation and Mitigation Strategy (REMS). This means that healthcare facilities, especially hospitals and associated outpatient clinics, can use these CAR-T cells after registration and successful testing.

Importantly for the European Union, Breyanzi® was granted PRIME (Priority Medicines) status for R/R DLBCL here. A Marketing Authorisation Application (MAA) is currently under review by the European Medicines Agency.

We are excited.

If you are looking for support for GMP-compliant manufacturing and approval of your ATMP, our ATMP experts will be happy to advise and accompany you. GMP for ATMPs | Valicare GmbH

Author: Dr. Petra Höhn, GMP Documentator, Valicare


1. Press release: https://www.businesswire.com/news/home/20210205005520/en/

2. Breyanzi Prescribing Information. Bristol Myers Squibb; February 2021.

3. American Cancer Society. Types of B cell Lymphoma. Available at: https://www.cancer.org/cancer/non-hodgkin-lymphoma/about/b-cell-lymphoma.html. Accessed February 2021.

4. Abramson JS, Palomba ML, Gordon LI, Lunning MA, Wang M, Arnason J, Mehta A, Purev E, Maloney DG, Andreadis C, Sehgal A, Solomon SR, Ghosh N, Albertson TM, Garcia J, Kostic A, Mallaney M, Ogasawara K, Newhall K, Kim Y, Li D, Siddiqi T. Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study. Lancet. 2020 Sep 19;396(10254):839-852.  1.

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