BTK Inhibitor Approved in Singapore for Relapsed/Refractory MCL

The Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib has been approved by the Health Sciences Authority of Singapore for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).

In June 2021, orelabrutinib was granted Breakthrough Therapy Designation for the treatment of relapsed or refractory MCL by the FDA. In December 2020, orelabrutinib received approval from the China National Medical Products Administration in two indications: relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma and relapsed or refractory MCL. At the end of 2021, orelabrutinib was included in the National Reimbursement Drug List in China.

Source: Business Wire, November 2022