BMS Submits sBLAs for Breyanzi in Relapsed/Refractory FL and MCL, Granted FDA Priority Review

On January 30, Bristol-Myers Squibb (BMS) announced that two supplemental Biologics License Applications (sBLA) for its CD19 CAR-T cell therapy Breyanzi (Lisocabtagene maraleucel, Liso-cel) have been accepted by the FDA and granted priority review for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) and mantle cell lymphoma (MCL) who have received BTK inhibitor (BTKi) therapy. The PDUFA dates are May 23, 2024, and May 31, 2024, respectively.

These two sBLAs are based on the positive results of the Phase II TRANSCEND FL study and the Phase I TRANSCEND NHL 001 study.

TRANSCEND FL Study is a global, multicenter, open-label, single-arm clinical trial that enrolled 130 patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma (NHL) who had received at least two prior lines of therapy (including patients with FL and marginal zone lymphoma), making it the largest clinical trial to date evaluating CAR-T cell therapy efficacy in this patient population. The results showed that the objective response rate (ORR) among 101 evaluable patients reached 97%, with 94% of patients achieving complete response (CR).

The TRANSCEND NHL 001 study is a multicenter, open-label, single-arm, seamless design clinical trial that enrolled 88 patients with relapsed or refractory MCL who had received at least two prior lines of therapy. The results showed that treatment with Breyanzi led to a statistically and clinically significant improvement in ORR (83.1%), with the majority (72.3%) of patients achieving CR; progression-free survival (PFS) was 15.3 months.

Breyanzi was first approved for marketing in the United States in February 2021, for the treatment of relapsed or refractory patients who have received two or more systemic therapies.Large B-Cell Lymphoma (LBCL)Adult patients, including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and grade 3B FL, unless otherwise specified.

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