The US Food and Drug Administration approved an update to the prescribing information for axicabtagene ciloleucel (Yescarta), removing the previous Limitations of Use for patients with relapsed or refractory primary central nervous system lymphoma (PCNSL).
The decision is based on positive safety data from a phase 1 investigator-sponsored study at Dana-Farber Cancer Institute. This decision makes axi-cel the only CD19-directed genetically modified autologous T-cell immunotherapy approved for R/R large B-cell lymphoma to have this specific restriction removed, according to a press release by Kite, a Gilead Company.
“We are pleased that our study, which highlighted the safety of axi-cel in central nervous system lymphoma, supported the FDA’s decision,” said Lakshmi Nayak, MD, director of the Center for CNS Lymphoma at Dana-Farber Cancer Institute and associate professor of neurology at Harvard Medical School.
