Antengene Corporation Limited today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) submitted by its partner Karyopharm Therapeutics Inc. for oral XPOVIO® (selinexor, ATG-010), a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) medicine, in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. This indication was approved three months ahead of its March Prescription Drug User Fee Act (PDUFA) date based on the result of a confirmatory Phase 3 BOSTON study.
XPOVIO® was previously approved under the FDA's Accelerated Approval Program for the treatment of adult patients with relapsed or refractory multiple myeloma (rrMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.
XPOVIO®, a first-in-class and only-in-class oral SINE compound, and now the first and only drug approved by FDA for use in both multiple myeloma and diffuse large B-cell lymphoma, discovered and developed by Karyopharm, is currently being developed by Antengene, who has the exclusive development and commercial rights in certain Asia-Pacific markets, including China. In December 2020, National Comprehensive Cancer Network (NCCN®) added three different XPOVIO® combination regimens to its Clinical Practice Guidelines in Oncology (NCCN® Guidelines) for previously treated multiple myeloma.
Antengene has conducted two Phase 2 registrational clinical trials of XPOVIO® in China for relapsed or refractory multiple myeloma (MARCH) and for relapsed or refractory diffuse large B-cell lymphoma (SEARCH). A Phase 3 randomized, controlled, open-label and multicenter BENCH trial has also received the IND approval from the National Medical Products Administration (NMPA) in China. Antengene is working on making XPOVIO® commercially available in Asia Pacific regions and has submitted the New Drug Applications (NDAs) for XPOVIO® to the Health Sciences Authority (HSA) of Singapore and the Australian Therapeutic Goods Administration (TGA) for three indications, including the treatment of patients with multiple myeloma who have received at least one prior therapy.
"This is the third approved indication for XPOVIO®, highlighting its potential of clinical application and broad market prospects. XPOVIO® offers patients with rrMM and their physicians the first oral SINE compound and makes more treatment options available to cancer patients with critical unmet medical needs." Dr. Jay Mei, M.D., Ph.D., Founder, Chairman and CEO of Antengene said, "We plan to launch XPOVIO® as soon as possible for the treatment of patients with rrMM and rrDLBCL in APAC following regulatory approvals, by leveraging our established commercial infrastructure and seasoned international team."
About the Phase 3 BOSTON Study
The approval of XPOVIO® in combination with once-weekly bortezomib plus low-dose dexamethasone (SVd) is supported by the results of the multi-center, Phase 3, randomized study, which evaluated 402 adult patients with relapsed or refractory multiple myeloma who had received one to three prior lines of therapy. The study was designed to compare the efficacy, safety and certain health-related quality of life parameters of once-weekly XPOVIO® (selinexor) in combination with once-weekly bortezomib plus low-dose dexamethasone (SVd) versus twice-weekly bortezomib plus dexamethasone (Vd). The primary endpoint of the study was progression-free survival (PFS) and key secondary endpoints included overall response rate (ORR), rate of peripheral neuropathy, and others. Additionally, the BOSTON study allowed for patients on the Vd control arm to crossover to the SVd arm following objective (quantitative) progression of disease verified by an Independent Review Committee (IRC). The BOSTON study was conducted at over 150 clinical sites internationally.
Although the...
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