Bristol-Myers Squibb has filed a biologics license application (BLA) with the FDA, which has been accepted by the agency and granted a priority review
Bristol-Myers Squibb has secured the US Food and Drug Administration (FDA) priority review for its lisocabtagene maraleucel (liso-cel), to treat a type of B-cell lymphoma.
The pharma company, through its wholly-owned subsidiary Juno Therapeutics, has filed a biologics license application (BLA) with the FDA, which has been accepted by the agency and granted a priority review, with 17 August 2020, as prescription drug user fee act (PDUFA) date.
liso-cel is an autologous, anti-CD19, chimeric antigen receptor (CAR) T-cell immunotherapy, which features a distinct composition of purified CD8+ and CD4+ CAR T cells, to treat relapsed or refractory (R/R) large B-cell lymphoma in adult patients, following at least two therapies.
The drug targets CD19, a surface glycoprotein expressed during normal B-cell development and maintained after the transformation of B cells into malignant.
Bristol-Myers Squibb has submitted liso-cel BLA based on TRANSCEND NHL 001 trial results
Bristol-Myers Squibb said that the BLA submission was supported by the safety and efficacy results from TRANSCEND NHL 001, a clinical trial of liso-cel on 268 patients with R/R large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL).
DLBCL is an aggressive form of non-Hodgkin lymphoma (NHL), which is considered to be the most common type of large B-cell lymphomas.
The company has previously secured the FDA breakthrough therapy and regenerative medicine advanced therapy designations for liso-cel, to treat specific types of B-cell lymphoma.
Bristol-Myers Squibb cellular therapy development senior vice president Stanley Frankel said: “There remains a critical need for additional therapies in large B-cell lymphoma, particularly for relapsed or refractory patients.
“Based on the TRANSCEND NHL 001 data, liso-cel has the potential to expand treatment options for those affected by this aggressive blood cancer who did not respond to initial therapies or whose disease has relapsed. This BLA acceptance and Priority Review designation is an important step as we work to improve treatment for these patients in need.”