Bristol Myers Squibb Co.’s Breyanzi (lisocabtagene maraleucel) CAR T-cell therapy has passed muster with European regulators as a therapy for relapsed or refractory large B-cell lymphoma, setting up a likely European marketing authorization in the coming weeks.
Bristol-Myers Squibb Co. has released top-line phase III results from its CAR T therapy Breyanzi (lisocabtagene maraleucel) that could support its use earlier in patients with refractory large B-cell lymphoma, outperforming standard stem cell transplant therapy.
While it’s too late to save the contingent value rights connected with the acquisition of Celgene Inc., Bristol Myers Squibb Co.’s CD19-targeted CAR T therapy, lisocabtagene maraleucel, for treating certain types of relapsed or refractory large B-cell lymphoma patients who have received at least two prior therapies, won FDA approval.
And just like that, it’s over. Bristol Myers Squibb Co. on Jan. 1 confirmed what many suspected, that FDA approval for lisocabtagene maraleucel (liso-cel) did not happen by the Dec. 31 deadline, thereby automatically terminating the contingent value rights (CVR) agreement issued as part of its acquisition of Celgene Inc.
Multiple companies have had their FDA reviews put on hold because coronavirus-related travel restrictions at the FDA has kept their manufacturing plants from being inspected.