XPOVIO® (Selinexor) Included in China's National Reimbursement Drug List for R/R DLBCL
Key Insights
Antengene (search)'s XPOVIO® (selinexor) gains NRDL inclusion in China for relapsed/refractory diffuse large B-cell lymphoma (search) (R/R DLBCL (search)) post two or more systemic therapies.
This marks XPOVIO®'s second indication in China to be included in the NRDL, enhancing patient access to this innovative treatment option.
XPOVIO®, a selective XPO1 (search) inhibitor, offers a novel mechanism of action and the convenience of oral administration for DLBCL (search) patients.
Antengene (search) Corporation Limited announced that XPOVIO® (selinexor) has been included in the 2024 China National Reimbursement Drug List (NRDL) for adult patients with relapsed or refractory diffuse large B-cell lymphoma (search) (R/R DLBCL (search)) who have received at least two prior lines of systemic therapy. The inclusion, effective January 1, 2025, marks a significant step in improving access to this innovative treatment for Chinese patients. This follows XPOVIO®'s initial approval for relapsed/refractory multiple myeloma (R/R MM) and subsequent approval for R/R DLBCL in China in July 2024.
Clinical Impact and Expert Opinion
Prof. Jun Zhu from Peking University Beijing Cancer Hospital emphasized the clinical significance of this development, stating, "As a novel inhibitor of the nuclear export protein, XPOVIO® has provided Chinese patients a new treatment option that offers a unique mechanism of action (MOA), clear efficacy, and convenience of use allowing patients to receive oral treatment at home and thereby significantly reduced the cost associated with inpatient treatment. The adoption of XPOVIO®'s indication in DLBCL (search) by the NRDL is great news for patients with R/R DLBCL as it will significantly improve the accessibility of this innovative drug."
XPOVIO®: Mechanism of Action and Global Availability
XPOVIO® is the world's first approved orally-available, selective inhibitor of the nuclear export protein XPO1 (search). By blocking XPO1, selinexor promotes the intranuclear accumulation and activation of tumor suppressor proteins and growth regulating proteins, while also down-regulating the levels of multiple oncogenic proteins. This unique mechanism of action leads to antitumor effects through multiple pathways, including inducing the intranuclear accumulation of tumor suppressor proteins, reducing oncogenic protein levels, and restoring hormone sensitivity.
Currently, XPOVIO® has been approved in nine countries and regions in the APAC area and is included in national insurance schemes in mainland China, Australia, Singapore, and South Korea. Antengene (search) is actively working to expand its availability in more APAC markets and explore new indications through combination regimens, including myelofibrosis (search) (MF) and endometrial cancer (search).
Antengene's Commitment
Antengene (search) remains committed to developing and commercializing innovative therapeutics for hematologic malignancies and solid tumors, with the goal of "Treating Patients Beyond Borders". The company has built a robust pipeline of oncology assets and continues to pursue clinical studies of XPOVIO® in mainland China for various relapsed/refractory hematologic malignancies and solid tumors.