Antengene Corp., Ltd. (HKG: 6996), a biopharmaceutical company based in China, has announced that it has received New Drug Application (NDA) approval from the regulatory authority in Macau for its product Xpovio (selinexor). This approval is specifically for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have undergone at least four prior therapies and whose condition is refractory to at least two proteasome inhibitors, two immunomodulatory agents, and an anti-CD38 monoclonal antibody (mAb) in combination with dexamethasone.
Xpovio, discovered by U.S.-based Karyopharm Therapeutics Inc. (NASDAQ: KPTI), is the first and only FDA-approved oral XPO1 inhibitor globally, designed for the treatment of hematological malignancies. Karyopharm licensed the rights to Xpovio to Antengene for Greater China, South Korea, and ASEAN countries in May 2018. To date, Xpovio has received approval in 42 countries and regions and is included in multiple treatment regimens for blood tumors within the diagnostic and treatment guidelines of seven major oncology societies and organizations across the U.S., Europe, and the Asia-Pacific region.- Flcube.com
