Selinexor Receives Commercialization Approval in Indonesia for Multiple Myeloma, DLBCL

Selinexor has been approved for commercialization for 3 disease indications in Indonesia by the Indonesia National Agency of Drug and Food Control (BPOM). The international biopharmaceutical company Antengene has developed this agent as XPOVIO and announced the new approval in a press release.

Two of the indications for which the New Drug Application (NDA) for selinexor was approved by the BPOM are for treatment of multiple myeloma in adults. The first is in combination with bortezomib and dexamethasone for patients who have had at least one prior treatment. The second is in combination with dexamethasone for patients who have had at least 4 prior treatments and for whom at least 2 immunomodulatory agents, at least 2 proteasome inhibitors, and an anti‐CD38 monoclonal antibody have been unsuccessful.

The third approved indication is as monotherapy for diffuse large B‐cell lymphoma (DLBCL) not otherwise specified in adults who are ineligible for hematopoietic stem cell transplant and who have had at least 2 lines of systemic therapy. This indication also includes DLBCL developing out of follicular lymphoma.

Selinexor is an orally available, selective inhibitor of the XPO1 nuclear export protein and the first agent of its kind to receive commercialization approval. It produces antitumor effects by inducing intranuclear accumulation of tumor suppressor proteins, as well as oncogenic mRNAs to decrease oncogenic proteins in the cytoplasm, and by restoring hormone sensitivity via activation of the glucocorticoid receptor pathway.

The NDA for selinexor is now approved in Australia, China, Hong Kong, Indonesia, Macau, Malaysia, Singapore, South Korea, Taiwan, and Thailand. The agent is also included within national insurance programs in Australia, China, Singapore, South Korea, and Taiwan.

Currently, Antengene has several clinical trials of combination regimens featuring selinexor to treat relapsed or refractory hematologic malignancies and solid tumors underway in China. Three of these trials are being carried out jointly with Karyopharm Therapeutics Inc. Antengene is also evaluating selinexor in combination regimens for additional conditions such as myelofibrosis and endometrial cancer.

Reference

XPOVIO® (selinexor) approved for commercialization in Indonesia, further expanding Antengene’s commercial presence in APAC. News release. PR Newswire. Published March 5, 2025. Accessed March 10, 2025. https://www.prnewswire.com/news-releases/xpovio-selinexor-approved-for-commercialization-in-indonesia-further-expanding-antengenes-commercial-presence-in-apac-302392606.html