Bristol Myers Squibb Receives European Commission Approval for Breyanzi (lisocabtagene maraleucel), a CD19-Directed CAR T-Cell Therapy, for Relapsed or Refractory Large B-cell Lymphoma
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The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
News on April 12, 2022 /BioValleyBIOON/ -- Bristol-Myers Squibb (BMS) recently announced that the European Commission (EC) has approved CD19CAR-TCell therapy Breyanzi (lisocabtagene maraleucel, liso-cel) for the treatment of large B-cellLymphoma(LBCL), specifically: relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), and grade 3B follicular lymphoma (FL3B) in adult patients who have previously received second-line or higher systemic therapy.
Breyanzi Marks the Second CAR-T Cell Therapy Approved by BMS in the EU. The drug is an autologous, CD19-directed, chimeric antigen receptor (CAR) T-cell therapy with a defined composition and 4-1BB co-stimulatory domain. Breyanzi consists of purified CD8+ and CD4+ T cells in a specific ratio (1:1), and the 4-1BB signaling enhances the expansion and persistence of Breyanzi.
Breyanzi represents a differentiated CAR-T cell therapy, demonstrating rapid, durable complete remission and manageable safety. Breyanzi delivers personalized treatment via a single infusion, showing sustained complete remission in a high proportion of R/R LBCL patients, with a controllable and differentiated safety profile.
This EU approval is based on the results of the TRANSCEND NHL 001 study. This study is the largest pivotal trial conducted in patients with relapsed or refractory large B-cell lymphoma (R/R DLBCL, PMBCL, FL3B) after second-line treatment, including patients with a wide range of histologies and high-risk disease. Among 216 patients treated with Breyanzi who were evaluable for efficacy, the objective response rate (ORR) was 73%, and the complete response rate (CR) was 53%. In patients who achieved a response, the median duration of response (mDOR) was 20.2 months. In patients achieving CR, the mDOR was 26.1 months.
The safety of Breyanzi is based on pooled data from 314 patients with R/R LBCL who received Breyanzi at doses ranging from 44 to 120 x 10E6 CAR+ viable T cells across four studies (TRANSCEND NHL 001, TRANSCEND WORLD, PLATFORM, OUTREACH). Cytokine release syndrome (CRS) of any grade occurred in 39% of patients, with 3% experiencing Grade 3 or 4 CRS. The median time to onset was 5 days (range: 1 to 14 days), and the median duration was 5 days (range: 1 to 17 days). Neurologic toxicity (NT) occurred in 26% of patients, with 10% experiencing Grade 3 or 4 NT. The median time to onset of the first NT event was 9 days (range: 1 to 66 days); 99% of NT cases occurred within the first 8 weeks after Breyanzi infusion. The median duration of NT was 10 days (range: 1 to 84 days).
The most common grade 3 or higher adverse reactions were neutropenia, anemia, thrombocytopenia, leukopenia, and unknown pathogens.InfectionAnd febrile neutropenia. (Bioon.com)
Source of the original text:Bristol Myers Squibb Receives European Commission Approval for CAR T Cell Therapy Breyanzi (lisocabtagene maraleucel) for Certain Forms of Relapsed or Refractory Large B-cell Lymphoma