Japan’s Ono Pharmaceutical (TYO: 4528) has received a supplemental approval for Velexbru (tirabrutinib) tablet 80mg, a Bruton’s tyrosine kinase (BTK) inhibitor, in Japan for additional indication of Waldenstrom macroglobulinemia and lymphoplasmacytic lymphoma, for a partial change in approved items of the manufacturing and marketing approval.
Originally approved in March this year, Ono Pharmaceutical launched Velexbru for the treatment of recurrent or refractory primary central nervous system lymphoma in Japan in May.
Clinical backing
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