Antengene Secures Approval for XPOVIO® to Treat DLBCL in Malaysia
On December 16, 2025, Antengene Corporation, a prominent biotech company, announced a major advancement in cancer treatment with the approval of XPOVIO® (selinexor) in Malaysia. The Malaysian National Pharmaceutical Regulatory Agency approved this drug specifically for adult patients suffering from relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after they have undergone at least two lines of systemic therapy and are ineligible for autologous stem cell transplant.
This recent development marks a significant expansion of XPOVIO®'s indications in Malaysia, which now encompasses three treatments, including multiple myeloma (MM) and DLBCL. Prior to this, XPOVIO® gained approval for two other indications: as a combination therapy with bortezomib and dexamethasone for patients with MM who had received at least one previous treatment, and also in combination with dexamethasone for those with MM after at least four prior treatments and where the disease is refractory to multiple therapies, including proteasome inhibitors and immunomodulatory agents.
The newly added indication for DLBCL offers a beacon of hope for many patients and their families who have been desperately seeking effective options. By delivering a novel mechanism of action, XPOVIO® stands out as the first oral selective inhibitor targeting XPO1 globally, already gaining approval across ten countries and regions in Asia-Pacific. Furthermore, out of those, five countries have integrated XPOVIO® into their national insurance schemes, including China, Taiwan, Australia, Singapore, and South Korea. Consequently, it is anticipated that more markets in the APAC region will soon follow suit with public insurance coverage for this critical therapy.
Antengene, while focused on developing innovative treatments for conditions with unmet medical needs, has set a robust track record. The company has obtained 32 investigational new drug (IND) approvals in the U.S. and Asia and submitted new drug applications in 11 Asia Pacific markets. At the core of their innovation is a diverse pipeline that spans from pre-clinical to commercial stages, including several self-discovered programs aimed at addressing a multitude of health challenges.
With XPOVIO® now extending its reach to include essential DLBCL treatment protocols, Antengene continues to solidify its commitment to breakthrough therapies. The continued progression of their promising pharmaceuticals demonstrates their dedication to combating complex diseases, paving the way towards better survival outcomes for patients worldwide. As Antengene looks forward to potential expansions of XPOVIO®, the medical and patient communities alike remain hopeful for the advancements this treatment can bring to those battling cancer.
In conclusion, the approval of XPOVIO® for DLBCL in Malaysia significantly enhances treatment opportunities for patients while underscoring Antengene's persistent efforts to lead innovations in the global biotech landscape. This leap in treatment potential not only supports individual patients but also promotes advances in the therapeutic field, eliciting hope for improved management of hematological malignancies.
This recent development marks a significant expansion of XPOVIO®'s indications in Malaysia, which now encompasses three treatments, including multiple myeloma (MM) and DLBCL. Prior to this, XPOVIO® gained approval for two other indications: as a combination therapy with bortezomib and dexamethasone for patients with MM who had received at least one previous treatment, and also in combination with dexamethasone for those with MM after at least four prior treatments and where the disease is refractory to multiple therapies, including proteasome inhibitors and immunomodulatory agents.
The newly added indication for DLBCL offers a beacon of hope for many patients and their families who have been desperately seeking effective options. By delivering a novel mechanism of action, XPOVIO® stands out as the first oral selective inhibitor targeting XPO1 globally, already gaining approval across ten countries and regions in Asia-Pacific. Furthermore, out of those, five countries have integrated XPOVIO® into their national insurance schemes, including China, Taiwan, Australia, Singapore, and South Korea. Consequently, it is anticipated that more markets in the APAC region will soon follow suit with public insurance coverage for this critical therapy.
Antengene, while focused on developing innovative treatments for conditions with unmet medical needs, has set a robust track record. The company has obtained 32 investigational new drug (IND) approvals in the U.S. and Asia and submitted new drug applications in 11 Asia Pacific markets. At the core of their innovation is a diverse pipeline that spans from pre-clinical to commercial stages, including several self-discovered programs aimed at addressing a multitude of health challenges.
With XPOVIO® now extending its reach to include essential DLBCL treatment protocols, Antengene continues to solidify its commitment to breakthrough therapies. The continued progression of their promising pharmaceuticals demonstrates their dedication to combating complex diseases, paving the way towards better survival outcomes for patients worldwide. As Antengene looks forward to potential expansions of XPOVIO®, the medical and patient communities alike remain hopeful for the advancements this treatment can bring to those battling cancer.
In conclusion, the approval of XPOVIO® for DLBCL in Malaysia significantly enhances treatment opportunities for patients while underscoring Antengene's persistent efforts to lead innovations in the global biotech landscape. This leap in treatment potential not only supports individual patients but also promotes advances in the therapeutic field, eliciting hope for improved management of hematological malignancies.
Topics Health）
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