Antengene’s XPOVIO approved in China for diffuse large B-cell lymphoma

Antengene Corporation Limited, a commercial-stage global biopharmaceutical company, has announced a significant milestone with the China National Medical Products Administration (NMPA) approving a new indication for XPOVIO (selinexor). This approval allows the use of XPOVIO as a monotherapy for adult patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL), one of the most common subtypes of non-Hodgkin lymphoma (NHL) in adults.

Diffuse large B-cell lymphoma presents significant treatment challenges due to its heterogeneity in clinical manifestations and prognosis. While the current standard treatments offer a progression-free survival rate of 60%-65% and curative outcomes for 40%-50% of patients, there remains a substantial subset of patients who either do not respond to first-line treatments or experience relapses. The approval of XPOVIO provides a crucial new treatment option for these patients.

The approval was supported by robust data from the registrational SEARCH study conducted in China. This study demonstrated the efficacy of selinexor in a cohort of 60 Chinese patients, showing significant response rates, durability of response, and extended survival benefits. The study’s results highlight the potential of selinexor to meet a critical need in the treatment landscape of R/R DLBCL.

“DLBCL is a significant health concern, and the approval of new, effective treatment options is crucial,” commented Prof. Jun Zhu, principal investigator of the SEARCH study from Peking University affiliated Beijing Cancer Hospital. He emphasized the importance of selinexor in providing a viable treatment option that can be administered orally, reducing hospital visits and the financial burden on patients.

XPOVIO, known for its unique mechanism of action as a selective inhibitor of the nuclear export protein XPO1, is now approved in over 40 countries and regions. This approval expands its reach, providing a new therapy option in markets with critical healthcare needs, including the APAC region where it is covered by health insurance in multiple countries.

XPOVIO works by blocking the nuclear export protein XPO1, promoting the accumulation and activation of tumor suppressor proteins while reducing oncogenic proteins. This mechanism provides a multi-faceted approach to combatting cancer, making XPOVIO a valuable addition to the arsenal against various hematologic malignancies and solid tumors.