FDA Grants Priority Review to Bristol Myers Squibb’s BLA for Lisocabtagene Maraleucel in Relapsed/Refractory Large B-Cell Lymphoma

Today, Bristol-Myers Squibb (BMS) announced that the U.S. FDA has accepted its Biologics License Application (BLA) for lisocabtagene maraleucel (liso-cel), a CD19-targeted CAR-T cell therapy, for the treatment of adult patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL), who have received at least two prior lines of therapy. Meanwhile, the FDA granted Priority Review designation, with a decision expected by August 17 this year.

Diffuse Large B-Cell Lymphoma (DLBCL) is the most common malignant lymphoma worldwide and represents an aggressive form of non-Hodgkin lymphoma (NHL). Approximately 30% to 40% of patients with DLBCL fail to achieve remission after first-line therapy or experience disease relapse. Patients who are ineligible for first-line treatment and unsuitable for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT) have a poor prognosis, highlighting an urgent need for additional therapeutic options.

Liso-cel is an autologous CAR-T therapy targeting the CD19 antigen. It has received Breakthrough Therapy Designation and Regenerative Medicine Advanced Therapy (RMAT) Designation from the U.S. FDA. The uniqueness of this therapy lies in the controlled ratio of CD8-positive to CD4-positive T cells within the CAR-T product, thereby enabling better management of the therapy’s adverse effects.

This application is based on the efficacy and safety data of liso-cel from the TRANSCEND NHL 001 clinical trial. The press release stated that this trial is the largest study to date supporting the submission of a Biologics License Application (BLA) for CD19-targeted CAR-T therapies. The trial results demonstrated that among 256 evaluable patients, the overall response rate (ORR) was 73%, with 53% of patients achieving a complete response (CR).

▲Efficacy data of liso-cel (Image source: BMS official website)

In terms of safety, severe (grade ≥3) cytokine release syndrome (CRS) occurred in only 2% of patients treated with this CAR-T therapy, and severe neurotoxicity of grade ≥3 was observed in only 10% of patients.

▲Safety data for liso-cel (Image source: BMS official website)

“For patients with large B-cell lymphoma, particularly those with relapsed or refractory disease, there is an urgent unmet need for additional therapeutic options,” said Stanley Frankel, M.D., Senior Vice President of Cell Therapy at Bristol-Myers Squibb. “Based on data from the TRANSCEND NHL 001 trial, liso-cel has the potential to expand treatment options for patients who have not achieved remission with initial therapy or whose disease has relapsed. The FDA’s acceptance of this application and its granting of Priority Review designation represent a significant step forward in improving the treatment landscape for these patients.”

References:

[1] U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol-Myers Squibb’s Biologics License Application (BLA) for Lisocabtagene Maraleucel (liso-cel) for Adult Patients with Relapsed or Refractory Large B-Cell Lymphoma, Retrieved February 13, 2020, from https://news.bms.com/press-release/us-food-and-drug-administration-fda-accepts-priority-review-bristol-myers-squibbs-biol

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