Overview
- Breyanzi becomes the only CD19-directed CAR T-cell therapy cleared for marginal zone lymphoma and its fifth approved indication overall.
- Approval is based on the TRANSCEND FL phase 2 cohort, where the intention-to-treat population had an 84.4% overall response rate and a 55.8% complete response rate, with median duration of response not reached.
- Bristol Myers Squibb reported a 95.5% response rate with 62.1% complete responses in a third-line-or-later analysis set, reflecting a different efficacy denominator than the intention-to-treat summary.
- Safety information cites cytokine release syndrome in 76% of patients, including 4.5% grade 3 or higher, with neurologic events such as headache and encephalopathy each seen in 21% of patients.
- The one-time list price is about $567,237, and the company says the therapy is broadly covered by commercial and government insurers.