Bristol/Myers Squibb said Wednesday it has submitted a Biologics License Applications (BLA) to the FDA, which includes data from Transcend NHL 001 trial, evaluating liso-cel in patients with relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma.
PRINCETON, N.J.–(BUSINESS WIRE)–$BMY #BLA—Bristol-Myers Squibb Company (NYSE: BMY) today announced the submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lisocabtagene maraleucel (liso-cel), its autologous anti-CD19 chimeric antigen receptor (CAR) T‑cell immunotherapy comprising individually formulated CD8+ and CD4+ CAR T cells for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after at least two prior therapies.
The submission is based on the safety and efficacy results from the TRANSCEND NHL 001 trial, evaluating liso-cel in 269 patients with relapsed/refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL). Bristol-Myers Squibb recently presented data from this pivotal study at the American Society of Hematology annual meeting.
Liso-cel has been granted Breakthrough Therapy (BT) and Regenerative Medicine Advanced Therapy (RMAT) designations by the FDA for relapsed/refractory aggressive large B-cell non-Hodgkin lymphoma (NHL), including DLBCL, not otherwise specified (de novo or transformed from indolent lymphoma), primary mediastinal B-cell lymphoma (PMBCL) or Grade 3B follicular lymphoma (FL) and Priority Medicines (PRIME) scheme by the European Medicines Agency for relapsed/refractory DLBCL.
Liso-cel is an investigational compound that is not approved for use in any country.
About Diffuse Large B-cell Lymphoma
Diffuse large B-cell lymphoma (DLBCL) is the most common and aggressive NHL, accounting for three out of every five cases. Approximately one-third of patients with DLBCL relapse after receiving first-line treatment, and about 10% have refractory disease. Historically, median life expectancy for patients who relapse or are refractory to current standard of care treatments is approximately six months.