ONO Reports Submission of MAA to MHLW for Tirabrutinib Hydrochloride to Treat Waldenstrom Macroglobulinemia and Lymphoplasmacytic Lymphoma
Shots:
- ONO has submitted manufacturing and marketing approval application to MHLW for the treatment of WM an LPL in Japan
- The application is based on P-II ONO-4059-05 study assessing Tirabrutinib in 27 patients with untreated recurrent or refractory WM and LPL. Additionally- ONO has applied for the manufacturing and marketing approval of Tirabrutinib to treat R/R PCNSL on Aug 28- 2019
- Tirabrutinib is a highly selective- oral BTK inhibitor- being developed for the treatment of patients with B-cell tumors and autoimmune diseases in Japan. In Dec’2014- ONO out-licensed Tirabrutinib to Gilead Sciences and granted rights to develop and commercialize the product globally excluding Japan- South Korea- Taiwan- China and Asian countries
Click here to read full press release/ article | Ref: ONO Pharmaceutical | Image: ONO Pharmaceutical
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