Breyanzi Label Expanded for the Third Time on May 31, 2024

Breyanzi Label Expanded for the Third Time on May 31, 2024

On Thursday, May 31, 2024, the U.S. Food and Drug Administration (FDA) approved Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL), making this CD19-targeted cellular therapy the broadest approved for B-cell malignancies.

Specifically, Breyanzi was approved for adult patients with relapsed or refractory MCL after receiving at least two prior systemic therapies, including a Bruton’s tyrosine kinase (BTK) inhibitor.

This approval was granted under priority review based on data from the phase 1 TRANSCEND NHL 001 study. Among 68 MCL patients treated with Breyanzi, 67.6% achieved a complete response. The median duration of response was 13.3 months, with a median follow-up of 22.2 months.

This is the third label expansion for a CAR-T therapy this year, and Breyanzi is now approved for four different types of non-Hodgkin’s lymphoma.

In March 2024, Breyanzi became the first CAR-T therapy approved for relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), and earlier this month, the FDA granted accelerated approval for this cellular therapy in relapsed or refractory follicular lymphoma. This one-time treatment was initially authorized in the U.S. in 2021 for third-line large B-cell lymphoma.

Breyanzi is increasingly becoming the preferred treatment for CLL. The U.S. Food and Drug Administration (FDA) on Thursday approved Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL), making this CD19-targeted cellular therapy the broadest approved for B-cell malignancies.

Breyanzi is increasingly becoming the preferred treatment for CLL.

Content Source:雪球