Will Breyanzi's Label Expansion Boost BMY's CAR T Cell Therapy Sales?

Bristol Myers Squibb BMY recently obtained FDA approval for the label expansion of Breyanzi (lisocabtagene maraleucel) for the treatment of adult patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy.

Breyanzi is a CD19-directed CAR T cell therapy that is already approved in the United States for the treatment of relapsed or refractory large B-cell lymphoma (LBCL) after at least one prior line of therapy. The therapy has also received accelerated approval for the treatment of R/R chronic lymphocytic leukemia or small lymphocytic lymphoma after at least two prior lines of therapy, and R/R follicular lymphoma (FL) after two or more prior lines of systemic therapy. It is approved for the treatment of relapsed or refractory mantle cell lymphoma (MCL) after at least two prior lines of systemic therapy.

The latest FDA approval makes Breyanzi the only CAR T cell therapy approved by the FDA for five cancer types.

Breyanzi was also recently approved in the EU for the treatment of adult patients with relapsed or refractory MCL after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase inhibitor. This approval from the European Commission marks the fourth approval for Breyanzi in Europe.

Breyanzi sales skyrocketed 100% to $966 million in the first nine months of 2025. Sales in the United States are being fueled by strong growth in large B-cell lymphoma and expansion in new indications approved last year. Outside the United States, sales are being boosted by continued strong demand across existing markets, along with added demand from newly launched markets.

We note that BMY is currently banking on the label expansion of approved drugs and approval of new drugs to stabilize its revenue base, as its legacy drugs (Revlimid, Pomalyst, Sprycel and Abraxane) face generic competition.

BMY Faces Competition for the CAR T Cell Therapy

Breyanzi faces competition from Gilead Sciences’ GILD Yescarta for its approved indications.

Gilead’s Yescarta is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with LBCL that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy. It is also approved for adult patients with relapsed or refractory LBCL after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from FL.

GILD has another CAR T cell therapy in its franchise, Tecartus.

Another approved CAR T therapy is Novartis’ NVS Kymriah, which is approved for acute lymphoblastic leukemia that is either relapsing or refractory. It is also used in patients with LBCL or FL, two types of non-Hodgkin lymphoma, who have relapsed or are refractory after having at least two other kinds of treatment. NVS’ Kymriah recorded sales of $296 million in the first nine months of 2025, down 12%.

NVS is also developing another CAR T cell therapy, YTB323, for LBCL.

BMY’s Price Performance, Valuation & Estimates

Shares of Bristol Myers have lost 8.2% year to date against the industry’s growth of 19.9%.

From a valuation standpoint, BMY is trading at a discount to the large-cap pharma industry. Going by the price/earnings ratio, BMY’s shares currently trade at 8.63x forward earnings, lower than its mean of 8.39x and the large-cap pharma industry’s 16.95X.

The Zacks Consensus Estimate for 2025 earnings per share has moved north in the past 60 days, while that for 2026 EPS has moved south.

BMY currently carries a Zacks Rank #3 (Hold).  You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

 

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This article originally published on Zacks Investment Research (zacks.com).

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