Shots:

• The approval was based on a P-I/II (ONO-4059-02) study evaluating the efficacy and safety of Velexbru (320/480mg, PO, qd) monothx. in 44 patients with recurrent or refractory PCNSL
• The results showed ORR {52.9% (9/17)} as assessed by an IRC in patients who received 480mg of Velexbru in the fasting with an approved dosage, grade 3 - 4 adverse drug reactions were observed in 11.8% (2/17) patients
• Velexbru is a highly selective, oral BTK inhibitor & has received manufacturing and marketing approval of Velexbru in Japan in March 2020 and launched in May 2020 for the treatment of r/r PCNSL. The therapy has received approval for the additional indication of WM and LPL

 Ref: Ono | Image: Ono USA