PRINCETON, N.J. – Bristol Myers Squibb (NYSE: NYSE:BMY) announced the FDA approval of Breyanzi (lisocabtagene maraleucel; liso-cel) for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two prior therapies, including a Bruton tyrosine kinase (BTK) inhibitor. This approval, based on the MCL cohort of TRANSCEND NHL 001 study results, extends Breyanzi's indication as the only CAR T cell therapy to cover four distinct subtypes of non-Hodgkin lymphoma.
MCL, an aggressive and often incurable form of non-Hodgkin lymphoma, presents significant treatment challenges, particularly after relapse. The TRANSCEND NHL 001 study demonstrated that 85.3% of evaluated patients responded to a one-time infusion of Breyanzi, with 67.6% achieving a complete response. These results indicate a potential new standard of care for patients with limited treatment options.
Breyanzi's safety profile has remained consistent across clinical trials, which included 702 patients. Cytokine release syndrome (CRS) occurred in 54% of patients, with Grade >3 CRS in 3.2%. Neurologic events (NEs) were reported in 31% of patients, including Grade >3 in 10%. The majority of these events were resolved with a median duration of 7 days.
The approval of Breyanzi is a significant development for patients fighting relapsed or refractory MCL, as noted by Meghan Gutierrez, CEO of the Lymphoma Research Foundation. Bristol Myers Squibb is prepared to meet demand for Breyanzi, with increased manufacturing capacity and broad coverage through commercial and government insurance programs in the U.S.
Breyanzi, a CD19-directed CAR T cell therapy, works by genetically reengineering a patient's own T cells to target and destroy cancer cells. It is already approved in the U.S. for other lymphoma subtypes and has received approval for certain indications in Japan, the European Union, Switzerland, the UK, and Canada.
This news is based on a press release statement from Bristol Myers Squibb.
InvestingPro Insights
Bristol Myers Squibb's (NYSE: BMY) latest FDA approval for Breyanzi highlights the company's continued strides in the pharmaceutical industry, particularly within the oncology segment. As the company garners positive attention for its innovative treatments, investors are keeping a close eye on the company's financial health and market performance.
One of the InvestingPro Tips to note is that Bristol Myers Squibb has a strong free cash flow yield, according to valuation metrics. This is a positive sign for investors, as it suggests the company is generating ample cash relative to its share price, which could provide the flexibility for further research and development, share buybacks, or dividend payments. Speaking of dividends, Bristol Myers Squibb has a notable track record, maintaining dividend payments for 54 consecutive years, which can be appealing for income-focused investors.
Looking at the real-time data from InvestingPro, Bristol Myers Squibb has a market capitalization of $82.04 billion and offers a high dividend yield of 5.96%, as of the latest data. Despite a slight decrease in revenue growth over the last twelve months, the company's gross profit margin remains robust at 76.03%, indicating strong profitability in the core aspects of its operations.
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With its latest clinical success and a solid financial foundation, Bristol Myers Squibb continues to demonstrate its prominence in the pharmaceutical industry and its potential for long-term investor value.
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