On March 1, 2022 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer and other life-threatening diseases, reported that XPOVIO(selinexor) has been granted approval from the Health Sciences Authority (HSA) in Singapore for three indications (Press release, Antengene, MAR 1, 2022, View Source [SID1234609305]):
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– Relapsed or refractory multiple myeloma (R/R MM) in combination with bortezomib and dexamethasone, for treatment of adult patients with R/R MM who have received at least one prior therapy
– Relapsed or refractory multiple myeloma (R/R MM) in combination with dexamethasone, for the treatment of adult patients with R/R MM who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody
– Relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) as monotherapy, for the treatment of adult patients with R/R DLBCL who have received at least two prior lines of treatment who are not eligible for haematopoietic cell transplant
Thomas Karalis, Head of APAC Markets commented: "Despite recent advances in the treatment of R/R MM and R/R DLBCL, there remains a continuing unmet need to extend survival for patients with these life-threatening diseases. The approval of XPOVIO presents Singapore physicians and patients with a novel addition to their existing regimens in their treatment of R/R MM and R/R DLBCL and we are very pleased to be launching XPOVIO in Singapore and across APAC markets in the coming months."
"I am very pleased for Antengene to receive clearance from HSA and to be able to bring XPOVIO, the first and only XPO1 inhibitor, to patients in Singapore with R/R MM and R/R DLBCL," said Dr. Jay Mei, Antengene’s Founder, Chairman and CEO. "Receiving regulatory clearance for three important indications at the same time enables Antengene to fulfill its mission to bring first-in-class/best-in-class medicines to patients with cancer and other life-threatening diseases in APAC markets and beyond."
Dr. Mei further commented: "Selinexor has been evaluated in more than 10 studies and widely adopted into practice guidelines by major oncology societies around the world. Over the last few years, we have been pleased to provide selinexor to 390 patients in Asia Pacific in an early access program. Now, our commercial team is well prepared to market the product in Singapore, building upon our commercialization experience with XPOVIO launches in China and South Korea."
About the SINE Compounds
SINE (Selective Inhibitor of Nuclear Export) compounds are inhibitors of the major nuclear export protein Exportin 1 (XPO1). Currently, there are three oral SINE compounds, ATG-010 (selinexor), ATG-016 (eltanexor), and ATG-527 (verdinexor), under clinical development. Antengene has an exclusive license from Karyopharm Therapeutics Inc. ("Karyopharm") to these compounds in certain APAC markets.
About XPOVIO/ATG-010/Selinexor
Selinexor is the first and only oral XPO1 inhibitor approved by the U.S. Food and Drug Administration (FDA). By blocking the nuclear export protein XPO1, selinexor can promote the intranuclear accumulation and activation of tumor suppressor proteins and growth regulating proteins, and down-regulate the levels of multiple oncogenic proteins. This induces apoptosis without affecting normal cells. Due to its novel mechanism of action, selinexor is being evaluated for use in multiple combination regimens to improve treatment efficacy.
Selinexor is approved by the US FDA for the treatment of R/R MM and R/R DLBCL.
Antengene secured approval of selinexor in China in December 2021 for R/R MM and plans to launch the product in the second quarter of 2022. Antengene also secured approval for selinexor in South Korea for use in R/R MM and R/R DLBCL in July 2021 and in Singapore for use in R/R MM and R/R DLBCL in March 2022. Antengene is conducting 10 studies in mainland China (3 in collaboration with Karyopharm) for relapsed/refractory hematological malignancies and advanced solid tumors.