ONO Reports Submission of MAA to MHLW for Tirabrutinib Hydrochloride to Treat Waldenstrom Macroglobulinemia and Lymphoplasmacytic Lymphoma

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

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