The European Commission approved Bristol‑Myers Squibb’s CAR‑T therapy Breyanzi (lisocabtagene maraleucel) for adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton's tyrosine kinase inhibitor, on November 24, 2025. The decision expands Breyanzi’s EU indication to a rare but aggressive form of non‑Hodgkin lymphoma, adding a new therapeutic area for the company’s CD19‑directed CAR‑T platform.
The approval was based on the TRANSCEND MCL trial, a single‑arm, phase I study that enrolled 73 heavily pre‑treated patients. The trial reported an overall response rate of 82.7 % and a complete response rate of 71.6 %. At 24 months, 50.8 % of patients remained in response, underscoring the durability of the therapy in a population with limited options.
Breyanzi’s commercial footprint has grown rapidly. In the first nine months of 2025, the drug generated $966 million in global sales, more than double the $484 million recorded in the same period a year earlier. The new MCL indication is expected to broaden the patient base and accelerate revenue growth, reinforcing Bristol‑Myers Squibb’s strategy to expand its high‑growth CAR‑T portfolio amid a competitive oncology landscape.
The MCL market remains underserved. While BTK inhibitors have transformed first‑line therapy, resistance and relapse are common, leaving a critical need for second‑line options. Other CAR‑T products, such as J&J’s Yescarta, target large B‑cell lymphoma but are not approved for MCL, giving Breyanzi a first‑mover advantage in this niche. The approval therefore positions BMY to capture a share of a high‑margin, high‑need market.
Emma Charles, senior vice president of the Europe region, said the approval “marks another important step as we continue to deliver on the promise of cell therapy for more eligible patients across Europe.” The decision aligns with BMY’s broader growth portfolio, which saw a 18 % year‑over‑year increase in Q3 2025, driven by strong demand for Breyanzi, Eliquis, and Opdivo.
Bristol‑Myers Squibb’s Q3 2025 earnings reflected the momentum. Revenue rose to $12.2 billion, up 3 % year‑over‑year, and non‑GAAP earnings per share reached $1.63, beating analyst expectations by $0.15. The company raised its full‑year 2025 revenue guidance to $47.5‑$48.0 billion and updated its non‑GAAP EPS range to $6.40‑$6.60, signaling confidence in sustained growth and the impact of the new MCL indication.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.