FDA extends action date for Bristol-Myers Squibb’s CAR-T for advanced large B-cell lymphoma
Click Here to Manage Email Alerts
The FDA has extended the action date by 3 months for the biologics license application of lisocabtagene maraleucel, a chimeric antigen receptor T-cell therapy for the treatment of adults with relapsed or refractory large B-cell lymphoma who have received two or more previous lines of therapy.
Lisocabtagene maraleucel (Bristol-Myers Squibb) is an autologous anti-CD19 CAR T-cell therapy that targets the CD19 antigen expressed on the surface of cancer cells.
The investigational compound contains a CAR construct composed of CD8 and CD4 CAR T cells and includes an anti-CD19 single-chain variable fragment that targets the specific antigen domain, a transmembrane domain, a 4-1BB costimulatory domain and a CD3-zeta T-cell activation domain.
Bristol-Myers Squibb submitted the BLA for lisocabtagene maraleucel to the FDA in December, as previously reported by Healio. The FDA granted the application priority review in February, with an original action date of Aug. 17.
The FDA has requested Bristol-Myers Squibb provide additional information, which was deemed a major amendment to the original BLA, according to a company-issued statement.
The FDA will need additional time to review the information and has established a new action date of Nov. 16.