Posted by Michael Wonder on 17 Feb 2022
U.S. FDA accepts for priority review Bristol Myers Squibb’s supplemental biologics license application for Breyanzi (lisocabtagene maraleucel) as a second-line therapy for relapsed or refractory large B-cell lymphoma
17 February 2022 - U.S. FDA has assigned a target action date of 24 June 2022.
Bristol Myers Squibb today announced that the U.S. FDA has accepted its supplemental Biologics License Application for Breyanzi (lisocabtagene maraleucel), a CD19 directed chimeric antigen receptor T cell therapy, to expand its current indication to include earlier use of Breyanzi for the treatment of adults with relapsed or refractory large B-cell lymphoma after failure of first-line therapy.
Read BMS press release
