Xpovio Approval Sought for Myeloma Indications in 3 Asian Pacific Markets

Xpovio Approval Sought for Myeloma Indications in 3 Asian Pacific Markets
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Antengene is asking health authorities in Singapore, Australia, and Hong Kong to approve Xpovio (selinexor) for the treatment of multiple myeloma, the company announced in a press release.

Specifically, the new drug applications will cover myeloma patients who have received at least four therapies, and failed to respond to at least two immunomodulatory therapies, two proteasome inhibitors, and one CD38 inhibitor.

Applications submitted in Singapore and Australia are requesting the addition of two other indications: for myeloma patients who received at least one line of therapy, in combination with Velcade (bortezomib) and dexamethasone; and for the treatment of diffuse large B-cell lymphoma (DLBCL) patients who received two or more lines of therapy.

The Australian Therapeutic Goods Administration accepted Antengene’s application for review on Dec. 2.

Xpovio, developed by Karyopharm Therapeutics, is a first-in-class oral inhibitor of the XPO1 protein that works by preventing the exit of tumor suppressor proteins from the cell nucleus. This leads to the death of cancer cells while leaving healthy cells unharmed.

The treatment has been approved in the U.S. for relapsed or refractory myeloma patients who have received at least four prior therapies and failed to respond to treatment, and for people with relapsed or refractory DLBCL, including DLBCL arising from follicular lymphoma.

A combination of Xpovio plus Velcade and dexamethasone is also being reviewed in the U.S. for those with multiple myeloma who have had at least one line of therapy, and the European Medicines Agency is considering an accelerated approval of Xpovio as a fifth-line or later myeloma treatment.

Under a collaboration with Karyopharm, Antengene owns the rights to develop and commercialize Xpovio across multiple regions, including mainland China, Macau, Hong Kong, AustraliaNew ZealandSouth KoreaTaiwan, and other Asian countries.

In addition to the recently submitted applications in Singapore, Australia, and Hong Kong, Antengene has received two orphan drug designations for Xpovio in South Korea, one for heavily treated myeloma and the other for DLBCL.

Two ongoing Phase 2 clinical trials in China may also support applications requesting Xpovio’s approval for triple-refractory myeloma patients and for relapsed or refractory DLBCL patients.

The MARCH trial (NCT03944057) is recruiting about 82 myeloma patients who received prior Velcade and Revlimid (lenalidomide) and failed to respond to immunomodulatory agents and proteasome inhibitors.

The SEARCH trial (NCT03992339) is enrolling about 60 patients with DLBCL who received between two and five prior lines of therapy, and are not eligible for high-dose chemotherapy plus stem cell transplant.

Antengene has also launched clinical trials examining Xpovio as a treatment for cancers that are highly prevalent in Asian Pacific regions, including peripheral T-cell lymphoma, NK/T-cell lymphoma, and KRAS-mutant non-small cell lung cancer.

Patricia holds her Ph.D. in Cell Biology from University Nova de Lisboa, and has served as an author on several research projects and fellowships, as well as major grant applications for European Agencies. She also served as a PhD student research assistant in the Laboratory of Doctor David A. Fidock, Department of Microbiology & Immunology, Columbia University, New York.
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Inês holds a PhD in Biomedical Sciences from the University of Lisbon, Portugal, where she specialized in blood vessel biology, blood stem cells, and cancer. Before that, she studied Cell and Molecular Biology at Universidade Nova de Lisboa and worked as a research fellow at Faculdade de Ciências e Tecnologias and Instituto Gulbenkian de Ciência. Inês currently works as a Managing Science Editor, striving to deliver the latest scientific advances to patient communities in a clear and accurate manner.
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Patricia holds her Ph.D. in Cell Biology from University Nova de Lisboa, and has served as an author on several research projects and fellowships, as well as major grant applications for European Agencies. She also served as a PhD student research assistant in the Laboratory of Doctor David A. Fidock, Department of Microbiology & Immunology, Columbia University, New York.
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