Antengene Receives Approval on XPOVIO® (Selinexor) for Multiple Myeloma and Lymphoma Treatment
Wednesday, March 05, 2025
Antengene has secured approval from Indonesia’s National Agency of Drug and Food Control (BPOM) for its New Drug Application (NDA) for XPOVIO® (selinexor).
XPOVIO® is the first orally available selective inhibitor of the nuclear export protein XPO1. By blocking this protein, it promotes the accumulation of tumour suppressor proteins in the nucleus, reduces levels of oncogenic proteins, and restores hormone sensitivity via glucocorticoid receptor activation. These mechanisms contribute to its effectiveness in treating various cancers.
The approval covers three indications:
In combination with bortezomib and dexamethasone for adult patients with multiple myeloma (MM) who have undergone at least one prior treatment.
In combination with dexamethasone for adults with relapsed or refractory multiple myeloma (R/R MM) after at least four prior therapies, including two proteasome inhibitors, two immunomodulatory agents, and an anti‐CD38 monoclonal antibody.
As a monotherapy for adults with relapsed or refractory diffuse large B‐cell lymphoma (R/R DLBCL), including cases arising from follicular lymphoma, after at least two lines of systemic treatment and ineligible for haematopoietic cell transplant.
XPOVIO® is the first orally available, selective XPO1 inhibitor to receive global approval and has been authorised in ten APAC markets.
It is also included in the national insurance schemes of China, Taiwan, Australia, Singapore, and South Korea.
Antengene is strengthening its presence in APAC to introduce more advanced medicines, improving healthcare access and patient outcomes.
Beyond geographic expansion, efforts are underway to extend the indications for XPOVIO®.
Research is ongoing into its use in combination regimens for conditions such as myelofibrosis and endometrial cancer.
Source: antengene.com
