Dec 18, 2019: Bristol-Myers Squibb Company announced the submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lisocabtagene maraleucel (liso-cel) and its autologous anti-CD19 chimeric antigen receptor (CAR) T‑cell immunotherapy comprising independently formulated CD8+ and CD4+ CAR T cells for the treatment of adult patients with the relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after at least two prior therapies.
This 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 the diffuse large B-cell lymphoma (DLBCL).
Recently, BMS presented data from this pivotal study at the American Society of Hematology annual meeting. Liso-cel is an investigational compound that is not approved for use in any of the country.
Diffuse large B-cell lymphoma (DLBCL) is the most common and aggressive NHL that accounts for three out of every five cases.
Around one-third of patients with DLBCL relapse after receiving first-line treatment, and approx 10% have refractory disease.
In the past, median life expectancy for patients who relapse or are refractory to the current standard of care treatments is approximately six months.
Combining these approaches is a solution of delivering new options for the treatment of cancer and addressing the growing issue of resistance to immunotherapy. https://news.bms.com/press-release/corporatefinancial-news/bristol-myers-squibb-announces-submission-biologics-license-ap
