Antengene Announces XPOVIO® (selinexor) Approved for Use in Malaysia
Tuesday, August 06, 2024
Antengene Corporation has received approval from the Malaysian National Pharmaceutical Regulatory Agency for XPOVIO® (selinexor). XPOVIO® is the world’s first oral selective XPO1 inhibitor and has been approved in eight APAC markets. Its introduction in Malaysia will provide new treatment options for MM patients and is expected to benefit many individuals and their families.
This approval covers two indications: (1) in combination with bortezomib and dexamethasone for adult patients with multiple myeloma (MM) who have had at least one prior therapy, and (2) in combination with dexamethasone for those with MM who have undergone at least four prior therapies and whose disease is resistant to two proteasome inhibitors, two immunomodulatory agents, and an anti-CD38 monoclonal antibody, with disease progression on the last therapy.
The ASEAN region, with its expanding economy and population over 600 million, represents a significant market for biomedical innovations. The ageing population is increasing the demand for new therapies. In response, Antengene has filed New Drug Applications for XPOVIO® in Thailand and Indonesia, with approvals anticipated later in 2024. The company plans to further expand its offerings in the region to improve healthcare outcomes.
Antengene is also exploring new indications for XPOVIO®. The drug’s novel mechanism of action is being evaluated in combination regimens for conditions such as myelofibrosis, T-cell non-Hodgkin’s lymphoma, and endometrial cancer. Current trials in mainland China are investigating its efficacy in treating various relapsed or refractory malignancies and solid tumours, with collaborations including Karyopharm Therapeutics Inc.
Source: antengene.com
