Selinexor Approved in Thailand for Two Adult MM Indications

The Thailand Food and Drug Administration has approved a New Drug Application (NDA) for commercialization of selinexor to treat adult patients with previously treated multiple myeloma (MM).

The approval of selinexor was for two indications in this patient population. The first was in combination therapy with bortezomib and dexamethasone. The second was in combination with dexamethasone for disease refractory to two immunomodulatory agents, two proteasome inhibitors, and an anti-CD38 monoclonal antibody.

Selinexor is a first-of-its-kind, orally available, selective inhibitor of the nuclear export protein exportin 1 (XPO1). It is produced by Antengene Corporation Limited and is marketed as XPOVIO®.

Selinexor has previously received NDA approvals for several indications in Australia, China, Hong Kong, Macau, Malaysia, Singapore, South Korea, and Taiwan, with a submitted NDA expected to be approved in Indonesia in the second half of 2024. It was also approved for health insurance coverage in Australia, China, Singapore, and South Korea.

“Leveraging the drug’s novel mechanism of action, Antengene is currently developing multiple combination regimens of XPOVIO® for the treatment of various indications including myelofibrosis, and endometrial cancer,” Antengene stated in a press release.

Multiple clinical studies are currently underway in China to evaluate this agent for such indications, and three of these studies Antengene is conducting jointly with Karyopharm Therapeutics Inc.