Antengene Corporation Limited (SEHK: 6996.HK), a global biotech company focused on innovative therapies for autoimmune diseases, solid tumors, and blood cancers, announced that Hong Kong’s Department of Health has approved two supplemental New Drug Applications (sNDAs) for XPOVIO® (selinexor).
The approvals cover:
XPOVIO® in combination with bortezomib and dexamethasone (XVd) for adult patients with multiple myeloma (MM) who have received at least one prior therapy.
XPOVIO® as monotherapy for adult patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL), including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy for patients ineligible for hematopoietic cell transplant.
Previously, XPOVIO® was approved in Hong Kong as part of the Xd regimen for relapsed/refractory multiple myeloma (R/R MM). These new approvals expand its availability to a broader patient population and offer potential survival benefits to more patients in need.
XPOVIO® is the world’s first orally available selective XPO1 inhibitor. It is approved in ten countries and regions across the Asia-Pacific (APAC) and is included in national insurance schemes in five markets: mainland China, Taiwan, Australia, Singapore, and South Korea. The company expects XPOVIO® to gain public insurance coverage in additional APAC markets in the future.
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