Onopharm (CEO Choi Ho-jin) announced on the 9th that it has received approval from the MFDS to sell BTK inhibitor Velexbrew as a monotherapy for patients with B cell-induced PCNSL.

The first BTK inhibitor has emerged as a PCNSL treatment that has not yet been established. The basis for approval is the results of phase 1/2 clinical trials (ONO-4059-02) evaluating the efficacy and stability of Velexbrew in patients with recurrent or refractory PCNSL in Japan. The first efficacy evaluation index was ORR according to BICR.

In this study, the ORR of the Velexbrew administered group was 52.9% (9/17 patients).

The main side effects of grades 3 and 4 included neutropenia, leukopeni