BTK inhibitor Velexbru approved in Taiwan

Japanese drugmaker Ono Pharmaceutical (TYO: 4528) says that its Taiwanese subsidiary has received an approval of Velexbru (tirabrutinib hydrochloride) tablet 80mg, a Bruton’s tyrosine kinase (BTK) inhibitor, from the Taiwan Food and Drug Administration (TFDA) for the treatment of adult patients with recurrent or refractory B-cell primary central nervous system lymphoma.

This approval is based on the results from a multicenter, open-label, uncontrolled Phase I/II study (ONO-4059-02), conducted in Japan, evaluating an efficacy and safety of Velexbru in patients with recurrent or refractory primary central nervous system lymphoma (PCNSL). In this study, the overall response rate (ORR) assessed by an independent review committee (IRC), a primary endpoint, was 52.9% (9/17 patients) in patients who received 480 mg of Velexbru in the fasting which is the approved dosage and administration this time. The major Grade 3 - 4 adverse drug reactions were neutropenia, leucopenia and hypertriglyceridemia which occurred each in 11.8% (2/17 patients).

Approval status