Antengene's Xpovio Receives Thailand FDA Approval for Multiple Myeloma
Key Insights
Thailand FDA approves Xpovio (selinexor) for multiple myeloma (search), marking its availability in nine APAC markets.
Xpovio, a selective XPO1 (search) inhibitor, is approved for use in combination with bortezomib and dexamethasone after one prior therapy.
The drug is also approved with dexamethasone after four prior therapies, addressing refractory cases.
Antengene (search) Corporation Limited announced that the Thailand Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Xpovio (selinexor) for treating adult patients with multiple myeloma (search) (MM). This approval covers two indications: in combination with bortezomib and dexamethasone for patients who have received at least one prior therapy, and in combination with dexamethasone for patients 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.
Xpovio is the world’s first approved orally-available, selective XPO1 (search) inhibitor. The drug's approval in Thailand marks its availability in nine markets across the APAC region. Antengene (search) anticipates Xpovio will introduce novel therapies into the clinical management of MM patients in Thailand.
Mechanism of Action and Clinical Use
Xpovio functions by blocking the nuclear export protein XPO1 (search), leading to the accumulation and activation of tumor suppressor proteins within the nucleus, while also reducing oncogenic protein levels. This mechanism exerts antitumor effects through multiple pathways, including inducing the intranuclear accumulation of tumor suppressor proteins, reducing oncogenic protein levels in the cytoplasm, and restoring hormone sensitivity by activating the glucocorticoid receptors (GR) pathway.
Antengene (search) is also striving to expand the indications of Xpovio and is currently developing multiple combination regimens of Xpovio for the treatment of various indications including myelofibrosis (search) (MF), and endometrial cancer (search).
Strategic Expansion in ASEAN
The ASEAN region, with a population exceeding 600 million, represents a significant market for biomedical development. The aging population in ASEAN has increased the demand for novel therapeutics. Antengene (search) has already secured NDA approvals for Xpovio in Malaysia in August and now in Thailand. The company expects Xpovio to be approved in Indonesia in the second half of 2024. Antengene aims to introduce more innovative medicines to the ASEAN market.