Selinexor Approved for Third Malignancy Indication in South Korea

The South Korean Ministry of Food and Drug Safety (MFDS) has approved a new supplemental New Drug Application (NDA) for use of selinexor (XPOVIO®) in combination with bortezomib and dexamethasone to treat multiple myeloma (MM) in adults who received at least one prior therapy.

This is the third indication for which selinexor has received regulatory approval in South Korea. The agent is already approved for use in combination with dexamethasone to treat adults with relapsed or refractory MM and as monotherapy for adults with relapsed or refractory diffuse large B-cell lymphoma.

“This recent approval for [selinexor] in South Korea will bring another innovative therapy to the clinical management of multiple myeloma patients in South Korea, benefiting countless patients and families,” Antengene officials stated in a press release.

Selinexor has already received NDA approvals for several indications in Australia, China, Hong Kong, Macau, Malaysia, Singapore, Taiwan, and Thailand, with a submitted NDA expected to be approved in Indonesia in the second half of 2024. As of July 2024, it is approved for public insurance coverage in South Korea and for national health insurance coverage or reimbursement in Australia, China, and Singapore.

At this time, Antengene has several clinical studies underway in China on XPOVIO® for indications including relapsed or refractory hematologic malignancies and solid tumors, with three such studies being conducted jointly with Karyopharm Therapeutics Inc. The company is also exploring use of XPOVIO® in combination regimens to treat additional diseases such as endometrial cancer and myelofibrosis.