China-based biopharmaceutical company Antengene Corp., Ltd (HKG: 6996) has announced receiving New Drug Application (NDA) approval from the Department of Health of Hong Kong. The approval is for the use of Xpovio in adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least four prior therapies. The treatment is indicated for patients whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody (mAb) combined with dexamethasone.
Xpovio: The First and Only FDA-Approved Oral XPO1 Inhibitor
Discovered by US-based Karyopharm Therapeutics Inc. (NASDAQ: KPTI), Xpovio is the world’s first and only FDA-approved oral XPO1 inhibitor, used for the treatment of hematological malignancies. Karyopharm licensed the rights for the drug to Antengene in Greater China, South Korea, and ASEAN countries in May 2018.
Global Approvals and Guidelines Inclusion
To date, Xpovio has been approved in 41 countries and regions, including the US, UK, the EU (27 countries), Canada, Norway, Iceland, Liechtenstein, South Korea, Mainland China, Singapore, Australia, and Northern Ireland. Xpovio’s treatment plans for blood tumors have been recognized and included in the diagnosis and treatment guidelines of seven professional oncology societies and organizations across the US, Europe, and the Asia-Pacific region.-Fineline Info & Tech
