FDA Approves Bristol-Myers Squibb's Breyanzi as First-Ever CAR T Therapy for Rare Marginal Zone Lymphoma

Bristol-Myers Squibb Company (NYSE:BMY) is one of the best stocks to buy for the next 5 years. On December 15, Goldman Sachs raised the firm’s price target on Bristol-Myers Squibb to $57 from $51, while maintaining a Neutral rating on the shares.

Earlier on December 4, Bristol-Myers Squibb announced that the US FDA approved Breyanzi (lisocabtagene maraleucel) for adult patients with relapsed or refractory (R/R) marginal zone lymphoma/MZL. This approval specifically applies to patients who have already received at least two prior lines of systemic therapy. With this milestone, Breyanzi becomes the first and only CAR T cell therapy approved for this patient population, and it now holds the record as the only CD19-directed CAR T therapy approved for five distinct types of B-cell malignancies.

The FDA’s decision was based on results from the MZL cohort of the TRANSCEND FL study, which demonstrated deep and durable responses. In the primary efficacy analysis of 66 patients, Breyanzi achieved an overall response rate of 95.5%, with 62.1% of patients reaching a complete response. The treatment showed remarkable longevity; while the median duration of response has not yet been reached, 90.1% of responders maintained their response at the 24-month mark. The therapy is administered as a one-time infusion and is designed for both inpatient and outpatient settings due to its established safety profile.

Safety data from the trial remained consistent with previous Breyanzi studies. The product carries Boxed Warnings regarding CRS, neurologic toxicities, and the potential for secondary hematological malignancies. Beyond MZL, Breyanzi is already approved for large B-cell lymphoma, chronic lymphocytic leukemia, small lymphocytic lymphoma, follicular lymphoma, and mantle cell lymphoma.

Bristol-Myers Squibb Company (NYSE:BMY) discovers, develops, licenses, manufactures, markets, distributes, and sells biopharmaceutical products worldwide. It offers products for oncology, hematology, immunology, cardiovascular, neuroscience, and other areas.

While we acknowledge the potential of BMY as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you’re looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock.

READ NEXT: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now.

Disclosure: None. This article is originally published at Insider Monkey.