Posted by Michael Wonder on 09 Nov 2023
US FDA accepts for priority review Bristol Myers Squibb’s application for Breyanzi (lisocabtagene maraleucel) for relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma
9 November 2023 - Application based on results from TRANSCEND CLL 004, the first pivotal multi-centre trial to show clinical benefit with a CAR T-cell therapy in heavily pre-treated patients with relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma, in which Breyanzi demonstrated deep and durable efficacy.
Bristol Myers Squibb today announced that the US FDA has accepted the supplemental biologics license application for Breyanzi (lisocabtagene maraleucel) to expand its current indication to include the treatment of adult patients with relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma who received a prior Bruton tyrosine kinase inhibitor and B-cell lymphoma 2 inhibitor.
