6 May 2020 - Bristol Myers Squibb today announced that the U.S. FDA has extended the action date by three months for the biologics license application for lisocabtagene maraleucel (liso-cel), a CD19-directed chimeric antigen receptor T cell therapy for the treatment of adults with relapsed or refractory large B-cell lymphoma after at least two prior therapies.
The new Prescription Drug User Fee Act action date set by the FDA is 16 November 2020.