Lymphoma drug submission from Ono banking on Phase I/II study
Ono Pharmaceutical (TYO: 4528) is relying on data from a Phase I/II study in 44 patients with its application for manufacturing and marketing approval of tirabrutinib hydrochloride to treat recurrent or refractory primary central nervous system lymphoma (PCNSL) in Japan.
Only last month, the Japanese Ministry of Health, Labour and Welfare granted the Bruton’s tyrosine kinase (BTK) inhibitor orphan drug status in PCNSL, a malignant lymphoma in which the lesion is localized in the cerebrospinal cord at the first onset.
High level of unmet need
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