Antengene submits New Drug Application for XPOVIO® in South Korea

Chinese biopharmaceutical firm, Antengene Corporation Ltd. has announced submitting a NDA (New Drug Application) with ODD (Orphan Drug Designation) to the Ministry of Food and Drug Safety (MFDS), South Korea for XPOVIO® (ATG-010), a first-in-class and only-in-class oral selective inhibitor of nuclear export (SINE).

According to reports, XPOVIO is orchestrated to be used in combination with low dose dexamethasone for treating adult patients with rrMM (relapsed/refractory multiple myeloma), and as a monotherapy to treat patients with rrDLBCL (relapsed/refractory diffuse large B-cell lymphoma).

It is worth mentioning that in October 2020, XPOVIO® was granted orphan drug designation in South Korea, while in December, Antengene’s US partner Karyopharm attained U.S. FDA approval for the drug to treat patients with multiple myeloma after one prior therapy.

As for the recent NDA submission, it includes positive data from the pivotal SADAL and STORM studies, which both showcased meaningful efficacy with a manageable safety profile for XPOVIO®.

Generally, the STORM study is a Phase 2b, single-arm, open-label study evaluating XPOVIO® plus low-dose dexamethasone in subjects with rrMM who have been treated with at least four prior therapies and whose disease is refractory to a minimum of two immunomodulatory agents, two proteasome inhibitors, and an anti-CD38 monoclonal antibody.

Whereas the SADAL study is a Phase 2b, open label study assessing XPOVIO® in patients with rrDLBCL, including DLBCL arising from follicular lymphoma, who have been subjected no less than two prior therapies.

Speaking on the move, Dr. Jay Mei, Founder, Chairman & CEO, Antengene, said that cases of blood cancers are increasing with age. Regardless of this, many healthcare providers still lack sufficient innovative therapies to help people with hematological malignancies, such as rrDLBCL and rrMM.

Dr. Mei said that Antengene is pleased about the regulatory filing of XPOVIO in APAC markets, including South Korea and their firm believes that oral ATG-010 will help enhance and improve treatment options for hematological malignancies and further present an efficient treatment for patients suffering from such life-threatening diseases.

Source Credit: https://www.prnewswire.com/news-releases/antengene-submits-nda-for-atg-010-selinexor-in-south-korea-for-rrmm-and-rrdlbcl-301199927.html