Bristol Myers Squibb's Breyanzi Becomes First CAR-T Therapy Approved for Marginal Zone Lymphoma
Key Insights
Bristol Myers Squibb (search)'s Breyanzi received FDA approval for treating relapsed or refractory marginal zone lymphoma (search), becoming the first cell therapy available for this rare lymphatic tumor.
The approval represents Breyanzi's fifth indication and addresses a significant unmet need in marginal zone lymphoma (search), which accounts for approximately 7% of all B-cell non-Hodgkin lymphoma (search) cases.
Breyanzi has demonstrated strong commercial performance with $747 million in sales in 2024 and $966 million over the first nine months of 2025.
The FDA has expanded the approved uses of Bristol Myers Squibb (search)'s CAR-T cell therapy Breyanzi, clearing it Thursday for treating certain relapsed or refractory cases of marginal zone lymphoma (search). This approval marks a significant milestone as Breyanzi becomes the first cell therapy available for this rare, slow-growing lymphatic tumor.
Addressing Unmet Medical Need in Rare Lymphoma
Marginal zone lymphoma (search) represents approximately 7% of all B-cell non-Hodgkin lymphoma (search) cases, according to the FDA. The condition has historically lacked targeted cellular therapy options, making this approval particularly significant for patients with relapsed or refractory disease who have exhausted conventional treatment approaches.
The new indication represents the fifth different approved use for Breyanzi, a cellular medicine that Bristol Myers inherited through its acquisition of Celgene. This expansion demonstrates the versatility of the CAR-T platform in addressing various hematologic malignancies.
Strong Commercial Performance
Breyanzi has established itself as a major revenue driver for Bristol Myers Squibb (search), generating $747 million in sales in 2024. The therapy's commercial momentum has continued into 2025, with $966 million in sales recorded over the first nine months of the year, indicating strong market adoption across its approved indications.
Broader Industry Developments
The pharmaceutical sector has seen several notable developments this week. Praxis Precision Medicines experienced a dramatic 40% surge in share price Friday following news that the company and FDA have aligned on requirements for an approval application for ulixacaltamide, an experimental treatment for essential tremor (search). The company now expects to file for approval early next year.
Praxis shares traded at $266 apiece mid-Friday morning, reflecting investor confidence following positive late-stage study results announced in October. The company also reported stopping a separate study early due to overwhelming efficacy for a different drug being tested in childhood encephalopathies (search).
Meanwhile, Denali Therapeutics secured up to $275 million through a royalty agreement with Royalty Pharma centered on tividenofusp alfa, which is currently under FDA review with an April 5 approval deadline. The deal includes $200 million upfront and an additional $75 million contingent on European Union approval by the end of the decade.