Antengene’s XPOVIO® Receives NMPA Approval for DLBCL Treatment in China
Introduction
Antengene Corporation Ltd. (“Antengene”), a global biopharmaceutical company, has announced that the China National Medical Products Administration (NMPA) has given its nod for the use of XPOVIO® (selinexor) as a monotherapy to treat adult patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). This is impressive news as XPOVIO® received approval as a monotherapy for relapsed or refractory multiple myeloma (R/R MM) treatment earlier.
Understanding R/R DLBCL
Diffuse large B-cell lymphoma (DLBCL) is one of the most prevalent subtypes of non-Hodgkin lymphoma in adults worldwide, and it is a highly heterogeneous malignancy with regards to its clinical manifestations and prognosis. While standard immunotherapy is considered the current treatment approach, it only offers five-year progression-free survival rates of 60%-65% and curative outcomes for only 40%-50% of treated patients.
Moreover, approximately 10-15% of DLBCL patients do not respond to the first-line treatment, and a further 20%-25% of patients experience relapses after initial responses. This means there is a significant unmet clinical need for more effective and convenient therapies to treat this condition.
XPOVIO®’s Novel Mechanism of Action
XPOVIO® is an orally administered drug that works by blocking the nuclear export protein XPO1, which promotes the intranuclear accumulation and activation of tumor suppressor proteins, growth regulating proteins, and down-regulates the levels of multiple oncogenic proteins. This process sets off three mechanistic pathways, including the intranuclear accumulation of tumor suppressor proteins that encourage antitumor effects, a reduction of oncogenic proteins in the cytoplasm by inducing the intranuclear accumulation of oncogenic mRNAs, and restoration of hormone sensitivity.
The SEARCH Study Results
The approval for the new indication of XPOVIO® was supported by the results of a study called “SEARCH” that enrolled 60 Chinese patients with DLBCL. According to the study, the central radiological review and the prespecified primary endpoint’s overall response rate (ORR) were both met. The study showed that orally administered selinexor monotherapy was significantly effective in Chinese patients, exhibiting a remarkable response rate, durable responses, and long survival.
Approval for XPOVIO® in Other Regions
XPOVIO® has received approval for health insurance coverage in Australia, Singapore, South Korea, and mainland China. Antengene submitted new drug approval applications (NDAs) for XPOVIO® in several other ASEAN markets, including Thailand, Malaysia, and Indonesia, with approvals anticipated in 2024’s second half.
Conclusion
The approval of XPOVIO® as a monotherapy in China for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) is a significant breakthrough. With the current standard treatment being immunotherapy, the approval provides welcome news for the 10-15% of DLBCL patients who do not respond to this first-line treatment. DARZALEX® may provide access to critical treatment options for adult patients with relapsed or refractory DLBCL.
Long-Tail Keywords:
- XPOVIO®
- Antengene Corporation
- China National Medical Products Administration (NMPA)
- relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL)
- non-Hodgkin lymphoma (NHL)
- tumor suppressor proteins
- immunotherapy
Originally Post From https://www.morningstar.com/news/pr-newswire/20240705cn55213/xpovio-selinexor-approved-for-new-indication-in-dlbcl-in-china-bringing-a-new-treatment-option-to-patients-in-the-country
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