China-based Antengene Corporation has announced that the Thailand Food and Drug Administration has approved a New Drug Application (NDA) for XPOVIO (selinexor) for two indications- (1) In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy; and (2) in combination with dexamethasone for the treatment of adult patients with MM who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

With a novel mechanism of action, XPOVIO is the world's first approved orally-available, selective XPO1 inhibitor, which has already been approved in nine markets in APAC. This successful approval for XPOVIO in Thailand will introduce novel therapies to the clinical management of patients with MM in Thailand, benefiting many patients and their families in the country. 

To date, XPOVIO has also been included in national health insurance or reimbursement schemes in the mainland of China, Australia, Singapore and South Korea.

The ASEAN region, with its steady economic growth and a population exceeding 600 million, has become a significant potential market for global biomedical development. The accelerating ageing population in ASEAN has increased the overall disease burden on patients and local communities, leading to a growing demand for novel therapeutics.

Antengene has successfully obtained NDA approvals for XPOVIO in Malaysia in August and very recently in Thailand, and expects XPOVIO to be approved in Indonesia in the second half of 2024. Looking ahead, the company aims to introduce more innovative medicines to the ASEAN market, bringing improved healthcare to more patients in the region.

Antengene is conducting multiple clinical studies of XPOVIO in the mainland of China for the treatment of relapsed/refractory hematologic malignancies and solid tumours, with 3 of these studies are being jointly conducted by Antengene and US-based Karyopharm Therapeutics Inc.