Antengene Corp., Ltd (HKG: 6996), a biopharmaceutical company based in China, has announced that it has received New Drug Application (NDA) approval in Thailand for its drug Xpovio (selinexor). This approval allows the use of Xpovio 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 can be used in combination with dexamethasone to treat 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 most recent therapy.
Xpovio, discovered by US-based Karyopharm Therapeutics Inc. (NASDAQ: KPTI), is the world’s first and only FDA-approved oral XPO1 inhibitor. In May 2018, Karyopharm granted Antengene the rights to the drug in Greater China, South Korea, and ASEAN countries. Xpovio has already been approved in mainland China, Hong Kong, Macau, South Korea, Singapore, Malaysia, and Australia, with reimbursement drug list coverage in mainland China, Australia, Singapore, and South Korea. The drug is also being evaluated in clinical trials for myelofibrosis (MF), T-cell non-Hodgkin lymphoma (T-NHL), and endometrial cancer in combination with other treatments.- Flcube.com
