(RTTNews) - Antengene Corporation Limited (6996.HK) announced that the Malaysian National Pharmaceutical Regulatory Agency has approved a supplemental New Drug Application (sNDA) for XPOVIO (selinexor). The approval covers the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after at least two lines of systemic therapy, who are ineligible for autologous stem cell transplant.
The latest approval expands XPOVIO's portfolio of indications in Malaysia to three, spanning multiple myeloma (MM) and DLBCL—two major therapeutic areas in hematology. Previously, XPOVIO was approved in Malaysia for use in combination with bortezomib and dexamethasone in adult patients with MM who had received at least one prior therapy, and in combination with dexamethasone for adult patients with MM who had received at least four prior therapies and whose disease was refractory to multiple classes of treatment. The new indication in DLBCL broadens access to XPOVIO, offering meaningful treatment options for patients and families urgently seeking effective therapies.
XPOVIO, with its novel mechanism of action, is the world's first approved orally available, selective XPO1 inhibitor. It has already received approvals in ten countries and regions across Asia-Pacific and is included in national insurance schemes in five of these markets, including mainland China, Taiwan, Australia, Singapore, and South Korea.
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