Antengene Corp., Ltd (HKG: 6996), a biopharmaceutical company based in China, has announced the approval of its New Drug Application (NDA) for Xpovio (selinexor) in Malaysia. The drug is now approved for use in combination with bortezomib and dexamethasone to treat adult patients with relapsed or refractory multiple myeloma (r/r MM) who have received at least one prior therapy. Additionally, it is approved in combination with dexamethasone for adult MM patients who have received at least four prior therapies and whose disease is refractory to multiple treatments, including proteasome inhibitors, immunomodulatory agents, and an anti-CD38 monoclonal antibody (mAb), with disease progression after the last treatment.
Xpovio, discovered by Karyopharm Therapeutics Inc. (Nasdaq: KPTI), is the first and only orally administered XPO1 inhibitor approved by the U.S. FDA. In May 2018, Karyopharm granted Antengene the rights to the drug in Greater China, South Korea, and ASEAN countries. With approvals in mainland China, Hong Kong, Macau, South Korea, Singapore, Malaysia, and Australia, Xpovio has been included in the reimbursement drug lists in mainland China, Australia, Singapore, and South Korea. The drug is also under assessment for potential use in myelofibrosis (MF), T-cell non-Hodgkin lymphoma (T-NHL), and endometrial cancer in combination with other therapeutics.- Flcube.com
