Bristol Myers wins FDA approval for Breyanzi in mantle cell lymphoma

Bristol Myers Squibb has achieved significant progress with its cell therapy, Breyanzi, securing its third FDA label expansion in just three months. Breyanzi has now been approved for treating specific patients with mantle cell lymphoma (MCL) who have relapsed or are unresponsive to at least two other therapies, one of which must include a BTK inhibitor.

This recent approval marks a milestone, making Breyanzi the first CAR-T cell therapy to earn FDA approval for four different subtypes of non-Hodgkin lymphoma. Initially approved by the FDA in 2021 for treating certain patients with relapsed or refractory large B-cell lymphoma, Breyanzi expanded its applications to this disease in 2022. 

Bristol Myers Squibb has been accelerating its regulatory efforts to broaden the uses of Breyanzi. In March, the therapy received an accelerated FDA nod for treating previously treated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This approval made Breyanzi the first cell therapy to enter the CLL/SLL market, which is typically dominated by BTK inhibitors such as BeiGene's Brukinsa.

Furthermore, just two weeks prior, Breyanzi secured FDA approval for treating patients with relapsed or refractory follicular lymphoma (FL) after at least two prior treatments. In this arena, Breyanzi joins competitor cell therapies from companies like Gilead Sciences and Novartis.

The most recent FDA approval for Breyanzi is based on the results from the MCL cohort of the TRANSCEND NHL 001 study. This study included patients who had undergone at least two lines of therapy, including a BTK inhibitor. The drug demonstrated a remarkable efficacy, with 85% of patients responding to the treatment and nearly 68% achieving a complete response. More importantly, over half of the responders maintained their response one year after receiving the one-time therapy.

Breyanzi is administered as a single infusion of genetically modified T cells derived from the patient. To support the drug's launch and meet market demands, Bristol Myers Squibb has significantly increased its manufacturing capacity, including the establishment of a production facility in Massachusetts, which received FDA approval last year.

In its latest announcement, Bristol Myers Squibb highlighted its ongoing investments to enhance manufacturing capacity to meet the growing demand for Breyanzi. The company's efforts seem to be paying off, with sales of the drug steadily increasing over the years. Breyanzi's revenue surged from $87 million in 2021 to $182 million in 2022, and further to $303 million in 2023.

According to Adam Lenkowsky, BMS's chief commercial officer, the recent label expansions are expected to "roughly double" the addressable patient population for Breyanzi. In addition to Breyanzi, Bristol Myers Squibb also markets another cell therapy for blood cancer known as Abecma, which generated $358 million in revenue last year.

Bristol Myers Squibb's efforts in expanding Breyanzi's applications and increasing its manufacturing capacity demonstrate the company's commitment to making advanced cell therapies accessible to a broader patient population. With continuous regulatory successes and growing sales figures, Breyanzi is set to play a significant role in the treatment landscape for various subtypes of lymphoma and other blood cancers.

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