China-based biopharma Antengene Corp., Ltd (HKG: 6996) has announced receiving fast-track designation from the US Food and Drug Administration (FDA) for its drug Xpovio (selinexor) in the treatment of myelofibrosis (MF), an indication that covers primary myelofibrosis, myelofibrosis after primary thrombocytosis, and myelofibrosis after polycythemia vera.
Background on Xpovio and Karyopharm Therapeutics
Discovered by US-based Karyopharm Therapeutics Inc., (NASDAQ: KPTI), Xpovio is the world’s first and only FDA-approved oral XPO1 inhibitor, used to treat hematological malignancies. Karyopharm licensed the rights for the drug to Antengene in Greater China, South Korea, and ASEAN countries in May 2018. The drug was first approved in the US to treat R/R MM and R/R DLBCL in 2019 and was conditionally approved in China in November 2021, before gaining market nods in Singapore and Australia in March 2022.
Initiation of Phase III XPORT-MF-034 Study
Karyopharm initiated the pivotal Phase III XPORT-MF-034 study in June 2023 to assess the safety and efficacy of selinexor combined with ruxolitinib in MF patients previously untreated with JAK inhibitors. Antengene plans to conduct the study in China mainland, Taiwan, and South Korea, among other Asia-Pacific countries and regions, further expanding the clinical reach of Xpovio in the treatment of myelofibrosis.-Fineline Info & Tech
