Antengene’s XPOVIO® Gains Third Approval in South Korea for Multiple Myeloma Treatment
Saturday, October 19, 2024
Antengene has announced that the South Korean Ministry of Food and Drug Safety (MFDS) has approved a supplemental New Drug Application (sNDA) for XPOVIO® (selinexor).
XPOVIO® works by inhibiting the nuclear export protein XPO1, which leads to the accumulation and activation of tumour suppressor proteins within the nucleus. This mechanism also down-regulates oncogenic proteins and restores hormone sensitivity.
The drug's effects are achieved through a combination of mechanisms, including enhancing the presence of tumour suppressor proteins, reducing oncogenic proteins in the cytoplasm, and activating the glucocorticoid receptor pathway.
The approval allows its use in combination with bortezomib and dexamethasone for adult patients with multiple myeloma (MM) who have undergone at least one prior therapy.
XPOVIO® had already received approval in South Korea for two other uses: in combination with dexamethasone for relapsed or refractory MM, and as a monotherapy for relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Earlier in July 2024, XPOVIO® was added to South Korea’s reimbursement drug list, making it the first XPO1 inhibitor to be covered by public insurance in the country.
XPOVIO®, which has a novel mechanism of action, is the world’s first orally-available selective XPO1 inhibitor. It has been approved in nine countries and regions in the Asia-Pacific (APAC) region and is included in national insurance schemes in South Korea, mainland China, Australia, and Singapore.
The recent approval in South Korea provides patients with multiple myeloma an additional therapeutic option.
Antengene is also working to extend XPOVIO®'s indications, exploring its potential in combination regimens for other diseases such as myelofibrosis and endometrial cancer.
The company is currently conducting several clinical trials in mainland China for the treatment of relapsed or refractory hematologic cancers and solid tumours, some of which are in collaboration with Karyopharm Therapeutics Inc.
Source: antengene.com
