Antengene Corporation Limited, a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, announces that its first commercialized product, the oral XPO1 inhibitor XPOVIO (selinexor) approved for the treatment of relapsed/refractory multiple myeloma (R/R MM), has officially entered multiple hospitals, online-hospitals, and direct-to-patient (DTP) pharmacies in mainland China and widely prescribed in the country for the first time at Shanghai Jiaotong University School of Medicine Ruijin Hospital, Shanghai Jiaotong University School of Medicine Renji Hospital, Tongji Hospital of Tongji University, Shanghai Sixth People’s Hospital, Shanghai Jiaotong School of Medicine St. Luke’s Hospital, and the PLA Naval Medical Center. By the end of May, selinexor will be expeditiously rolled out to approximately 600 hospitals and 105 DTPs in over 30 provinces, autonomous regions, and municipalities including Beijing, Shanghai, Guangdong, Jiangsu, Zhejiang, Henan, and Shandong, providing Chinese MM patients across the country with an easy to access to this new treatment option.
Multiple myeloma (MM) is the second most common hematologic malignancy in China, accounting for approximately 10% of all hematologic malignancy incidences. The number of new diagnoses of MM has been rising year after year, thus presenting a rapidly growing medical need.[1] Strikingly, more patients are diagnosed at younger ages.
The prior standard of care for MM has been based on treatment with a combination of therapies including dexamethasone, proteosome inhibitors, immunomodulatory agents and an anti-CD38 monoclonal antibody. Despite the availability of these therapies, MM remains a hard-to-treat cancer. Most patients with MM experience at least one relapse,[2][3] with each relapse resulting in a shorter duration of response. In particular, those patients relapsed after third- or forth-line treatments have a poor prognosis and limited treatment options,[4][5] with a median progression-free survival (PFS) of only 3-6 months and an overall survival (OS) of about 6 months.
In July 2019, the U.S. Food and Drug Administration (FDA) approved a new drug application (NDA) for XPOVIO® , the world’s first oral selective inhibitor of nuclear export protein-1 (XPO1) approved for combination use with low-dose dexamethasone for the treatment of patients with R/R MM who have received at least four prior therapies and whose disease is refractory to at least two proteosome inhibitors, at least two immunomodulatory agents and an anti-CD38 monoclonal antibody. Less than a year after that, the FDA granted approval for another indication for XPOVIO®, as a monotherapy for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL). In December 2020, XPOVIO® obtained its third FDA-approved indication, for combination use with bortezomib and dexamethasone in treatment of adult patients with MM who previously received at least one prior therapy.