Bristol Myers Squibb's Breyanzi Secures FDA Approval for Fifth Blood Cancer Indication

Bristol Myers Squibb (BMS) has achieved a significant milestone in the field of cell therapy as its CAR-T treatment, Breyanzi, received FDA approval for the treatment of marginal zone lymphoma (MZL). This latest endorsement marks Breyanzi as the first CAR-T therapy to be approved for five different types of blood cancer, further solidifying BMS's position in the competitive CAR-T market.

Breyanzi's Expanding Portfolio

The U.S. Food and Drug Administration (FDA) has approved Breyanzi for adult patients with relapsed or refractory MZL who have received at least two lines of prior therapy. This approval adds to Breyanzi's existing indications, which include:

1. Large B-cell lymphoma
2. Mantle cell lymphoma (MCL)
3. Follicular lymphoma (FL)
4. Chronic lymphocytic lymphoma (CLL)
5. Small lymphocytic lymphoma (SLL)

With this latest approval, BMS gains a competitive edge over Gilead Sciences, whose CD19-directed CAR-T therapies, Yescarta and Tecartus, are approved for a combined four blood cancer indications.

Clinical Efficacy and Safety Profile

The FDA's decision was based on results from the phase 2 Transcend FL trial, which demonstrated Breyanzi's efficacy in treating MZL. Key findings include:

• 95% overall response rate among 66 enrolled MZL patients
• 62% of participants achieved a complete response
• 90% of responders maintained their response through 24 months

Dr. M. Lia Palomba, a lymphoma and cell therapy specialist at Memorial Sloan Kettering Cancer Center and study investigator, highlighted the significance of this approval, stating, "This is a significant advancement in redefining the treatment landscape and providing patients with an option that has demonstrated high rates of responses with an established safety profile."

However, the treatment is not without risks. The study reported cytokine release syndrome (CRS) in 76% of patients, as well as various nervous system disorders including headache, tremor, encephalopathy, dizziness, and aphasia.

Market Impact and Financial Performance

The approval of Breyanzi for MZL treatment is expected to bolster BMS's position in the CAR-T market. Recent financial data indicates:

• Breyanzi's Q3 revenues increased by 58% to $359 million
• Year-to-date sales of $907 million, positioning Breyanzi to achieve blockbuster status for the first time

In contrast, Gilead's CAR-T revenues have seen a decline, with Q3 sales down 10% for Yescarta and 15% for Tecartus. Their combined Q3 sales totaled $432 million.

BMS's success with Breyanzi can be traced back to its strategic acquisitions, including the $74 billion purchase of Celgene in 2019, which had previously acquired Juno Therapeutics for $9 billion.

As the CAR-T therapy landscape continues to evolve, BMS's Breyanzi is poised to play a significant role in shaping the future of blood cancer treatment, offering new hope for patients with limited options.