Bristol‑Myers Squibb announced that the U.S. Food and Drug Administration approved its CAR‑T therapy Breyanzi (lisocabtagene maraleucel) for adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy. The approval, granted on December 4, 2025, adds a fifth cancer type to Breyanzi’s U.S. portfolio and expands the drug’s market reach into a disease that accounts for roughly 7% of all non‑Hodgkin lymphoma cases.
The pivotal TRANSCEND FL study, which included a 66‑patient MZL cohort, reported an overall response rate of 95.5% and a complete response rate of 62.1%. 88.6% of responders maintained their response at 24 months, underscoring the durability of the therapy in this indolent but relapsing disease. These data support the FDA’s decision and position Breyanzi as the only CD19‑directed CAR‑T product approved for five distinct B‑cell malignancies.
Financially, Breyanzi generated $747 million in global sales in 2024 and $966 million in the first nine months of 2025. The new MZL indication is expected to push the drug past the $1 billion sales threshold this year, reinforcing Bristol‑Myers Squibb’s leadership in cell‑therapy oncology and providing a significant revenue driver in a high‑margin segment.
Lynelle B. Hoch, President of the Cell Therapy Organization, said, “The FDA approval of Breyanzi for relapsed or refractory marginal zone lymphoma further solidifies it as the leading CD19‑directed CAR‑T cell therapy covering the broadest range of B‑cell malignancies. This approval in a fifth cancer type reflects our bold vision to bring the transformational potential of cell therapy to more patients.” The quote highlights the company’s confidence in Breyanzi’s expanding therapeutic footprint.
Strategically, the approval strengthens Bristol‑Myers Squibb’s competitive advantage over other CAR‑T products such as Gilead’s Yescarta and Tecartus, which together cover four blood‑cancer indications. By adding MZL, Breyanzi becomes the sole CAR‑T therapy with five U.S. approvals, positioning the company to capture a larger share of the growing cell‑therapy market and to leverage its existing manufacturing and distribution infrastructure.
The approval also signals robust demand for cell‑therapy solutions, aligning with Bristol‑Myers Squibb’s broader “bold vision” to expand the reach of transformative therapies. With the drug poised to exceed $1 billion in sales, the company’s revenue mix will shift further toward high‑margin oncology products, supporting long‑term growth and shareholder value.
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