XPOVIO®

Dec 29, 2021View PDF

XPOVIO® (希维奥®, selinexor, ATG-010) is a highly potent and a first-in-class, oral selective inhibitor of nuclear export (SINE) compound.

In July 2021, XPOVIO® was approved via a priority review process by the South Korean Ministry of Food and Drug Safety (MFDS), in combination with dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma (rrMM) 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 (penta-refractory); and as a monotherapy for the treatment  of adult patients with relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL) who have received at least two prior lines of treatment.

In Mar 2022, XPOVIO® NDA was approved by Health Sciences Authority(HSA) of Singapore, In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma 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; and for the treatment of adult patients with relapsed or refractory diffuse large B‐cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy who are not eligible for haematopoietic cell transplant.

In Mar 2022, XPOVIO® NDA was approved by Therapeutic Goods Administration(TGA) of Australia, in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least 3 prior therapies and whose disease is refractory to at least one proteasome inhibitors (PI), at least one immunomodulatory agents (IMiD), and an anti-CD38 monoclonal antibody (mAb). 

Antengene has exclusive development and commercialization rights to XPOVIO in certain Asia Pacific markets including greater China.

For Medical inquiries about XPOVIO® (Selinexor), please contact: medinfo@antengene.com 

 

Adverse Event Reporting

If you would like to report any suspected adverse events, please contact us with:

 

Country

Contact information

China

Hotline: 400-8217000

Email: ae@antengene.com

Singapore

Hotline: 0065-67278471

Email: ae@antengene.com

Korea

Hotline: 080-508-3243

Email: safety.korea@antengene.com

Australia

Hotline: 1800 978 284 (option 5)

Email: safety.australia@antengene.com 

Because the information involves adverse event of Antengene products, the information and data of relevant patients/reporters you provide will be disclosed to Antengene pharmacovigilance department. The information will be entered into Antengene pharmacovigilance database and report to relevant regulatory authorities in accordance with relevant laws and regulations. Antengene may follow up with the information reporter regarding this event.

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