XPOVIO® (selinexor) Approved for New Indication in DLBCL in China, Bringing a New Treatment Option to Patients in the Country
- Following its initial approval for the treatment of relapsed/refractory multiple myeloma (R/R MM), XPOVIO® has now received approval as a monotherapy for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) marking the second approved indication of XPOVIO® in
- Results from the registrational SEARCH study in
- XPOVIO® is an oral drug with a novel mechanism of action.
- XPOVIO® has been approved for health insurance coverage in the mainland of China,
A Novel Therapy Bringing Long-awaited Clinical Breakthrough to the Treatment of R/R DLBCL
DLBCL is one of the most common subtypes of non-Hodgkin lymphoma (NHL) in adults and is highly heterogeneous malignancy in both clinical manifestations and prognosis. The current standard treatment, immunotherapy, offers patients with DLBCL a five-year progression-free survival rate of 60%-65% and curative outcomes for 40%-50% of treated patients. However, 10%-15% of DLBCL patients do not respond to standard first-line treatment, and 20%-25% experience relapses after achieving initial responses, leading to a poor prognosis and enormous unmet clinical needs.
The Clinically Validated Efficacy and Convenience of
The approval for the new indication was supported by data from the registrational SEARCH study in China. Results from the study, which enrolled a total of 60 Chinese patients with DLBCL, showed that patients treated in the trial achieved a central radiological review assessed overall response rate (ORR) meeting the pre-specified primary endpoint. The SEARCH study demonstrated clear efficacy of orally-administered selinexor monotherapy in Chinese patients, exhibiting significant response rates, durable responses, long survival.
Prof.
Approved in 40+ Markets Globally with Expanding Insurance Coverage Across APAC
With a novel mechanism of action, XPOVIO® is the world's first approved orally-available, selective XPO1 inhibitor. XPOVIO® has a global commercial presence with approvals in over 40 countries and regions. To date, XPOVIO® has already been included for health insurance coverage in the mainland of China,
About XPOVIO® (selinexor)
XPOVIO® is the world's first approved orally-available, selective inhibitor of the nuclear export protein XPO1. It offers a novel mechanism of action, synergistic effects in combination regimens, fast onset of action, and durable responses.
By blocking the nuclear export protein XPO1, XPOVIO® can promote the intranuclear accumulation and activation of tumor suppressor proteins and growth regulating proteins, and down-regulate the levels of multiple oncogenic proteins. XPOVIO® delivers its antitumor effects through three mechanistic pathways: 1) exerting antitumor effects by inducing the intranuclear accumulation of tumor suppressor proteins; 2) reducing the level of oncogenic proteins in the cytoplasm by inducing the intranuclear accumulation of oncogenic mRNAs; 3) restoring hormone sensitivity by activating the glucocorticoid receptors (GR) pathway. To utilize its unique mechanism of actions, XPOVIO® is being evaluated for use in multiple combination regimens in a range of indications. At present,
About
Since 2017,
Forward-looking statements
The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, please see the other risks and uncertainties described in the Company's Annual Report for the year ended
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