Bristol Myers’ Breyanzi Now FDA-Approved for Earlier Lymphoma

The latest FDA approval means Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel) is now the leading CAR T-cell therapy for relapsed or refractory large B-cell lymphoma (LBCL), rapidly catching up with Gilead Sciences’ Yescarta which also secured the similar indication earlier this April.

“With this approval, Breyanzi now has the broadest patient eligibility of any CAR T therapy in relapsed or refractory LBCL, reinforcing company’s leadership in delivering innovative cancer treatments with Breyanzi as a cornerstone of its diversified cell therapy portfolio and pipeline,” Bristol Myers Squibb said in a press release.

Breyanzi now covers adults with refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy, this new approval also extends its therapeutic indications to include patients who are not eligible for hematopoietic stem cell transplant (HSCT).

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Breyanzi’s Better EFS Improvements in Phase 3 TRANSFORM Trial

The FDA based the decision on Bristol Myers Squibb’s Phase 3 TRANSFORM trial, which evaluated Breyanzi in comparison to standard chemotherapy followed by stem cell transplant. Breyanzi demonstrated an event-free survival (EFS) of 10.1 months vs. 2.3 months in standard treatments, and the majority of patients (66%) achieved complete response. While Gilead’s Yescarta registered a smaller reduction (8.3 months vs. 2.0 months) on a similar event-free survival metric in its Phase 3 ZUMA-7 trial. Breyanzi’s results also showed that it more than doubled progression-free survival versus standard therapy.

“Patients with large B-cell lymphoma whose disease does not respond to or relapses after first-line therapy often face lengthy and intensive cycles of chemotherapy with the goal of proceeding to stem cell transplant,” said Lee Greenberger, Ph.D., Chief Scientific Officer of the Leukemia & Lymphoma Society (LLS). 

Up to 40% of LBCL patients are estimated to have refractory disease or relapses after initial therapy, around half of these patients are not eligible for a stem cell transplant due to comorbidities. This approval opens up avenues for Breyanzi treatment, instead of Gilead’s Yescarta.

Breyanzi generated $87 million in 2021 and is projected to reach $3 billion by 2029.

Author

Fujie Tham