Antengene Submits NDA for ATG-010 (Selinexor) in South Korea for rrMM and rrDLBCL
SHANGHAI and HONG KONG: Antengene Corporation Limited, a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in class therapeutics in hematology and oncology, announced that it has submitted a New Drug Application (NDA) with Orphan Drug Designation (ODD) to the South Korean Ministry of Food and Drug Safety (MFDS) for ATG-010 (selinexor, XPOVIO®) in combination with low dose dexamethasone for the treatment of adult patients with relapsed/refractory multiple myeloma (rrMM) and for ATG-010 (selinexor, XPOVIO®) as monotherapy to treat adult patients with relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL). ATG-010 (selinexor, XPOVIO®) was granted orphan drug designation in South Korea in October 2020 and our US partner Karyopharm received U.S. Food and Drug Administration (FDA) approval for the treatment of patients with multiple myeloma after at least one prior therapy on December 18, 2020.
The NDA submission includes positive data from the pivotal STORM and SADAL studies, which both demonstrated significant and meaningful efficacy with a manageable safety profile for ATG-010 (selinexor, XPOVIO®). The STORM study is a Phase 2b, open-label, single-arm study evaluating ATG-010 (selinexor, XPOVIO®) plus low-dose dexamethasone in patients with rrMM who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents, and an anti-CD38 monoclonal antibody. The SADAL study is a Phase 2b, open label study evaluating ATG-010 (selinexor, XPOVIO®) in patients with rrDLBCL, not otherwise specified, including DLBCL arising from follicular lymphoma, who have received at least two prior therapies.
ATG-010 (selinexor, XPOVIO®) is a first-in-class and only-in-class oral selective inhibitor of nuclear export (SINE) and it is the first drug approved by the FDA for use in both multiple myeloma and diffuse large B-cell lymphoma. In December 2020, the National Comprehensive Cancer Network (NCCN®) added three different triplet ATG-010 (selinexor, XPOVIO®) combination regimens, including SVd (selinexor, bortezomib and dexamethasone), SPd (selinexor, pomalidomide and dexamethasone) and SDd (selinexor, daratumumab and dexamethasone) to its Clinical Practice Guidelines in Oncology (NCCN® Guidelines) for previously treated multiple myeloma in the US. Antengene has submitted NDAs to the Health Sciences Authority (HSA) of Singapore and to the Australian Therapeutic Goods Administration (TGA) for ATG-010 in patients with rrMM and in patients with rrDLBCL.
"The incidence of blood cancers increases with age, yet many healthcare providers still do not have sufficient innovative therapies available to help people with hematological malignancies, such as rrMM and rrDLBCL," Dr. Jay Mei, Founder, Chairman and CEO of Antengene said, "We are excited about the regulatory filing of ATG-010 in APAC markets, including South Korea. We believe that oral ATG-010 will expand and improve treatment options for hematological malignancies and therefore presents a significant advancement for patients requiring treatment of these life threatening diseases."
