BRIEF—Filing for novel cancer med tirabrutinib

Osaka-based Ono Pharmaceutical has filed for Japanese approval for tirabrutinib, also known as ONO-4059, for people with Waldenstrom macroglobulinemia (WM) and lymphoplasmacytic lymphoma (LPL).

The filing for tirabrutinib, a Bruton’s tyrosine kinase (BTK) inhibitor and Orphan Drug-designated candidate, is based on data from the Phase III ONO-4059-05 study.

It is estimated that there are approximately 240 new people with LPL per year in Japan.

Ono has out-licensed global rights to the candidate, except for in Japan, South Korea, Taiwan, China and ASEAN countries, to Gilead Sciences.