Pharmaceutical Japan’s Ono Pharmaceutical today announced that the US Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) under the accelerated approval pathway for tirabrutinib, a highly selective irreversible, second generation Bruton’s tyrosine kinase inhibitor (BTK), for the treatment of relapsed or refractory primary central nervous system lymphoma (R/R PCNSL). 16 February 2026