China's oncology firm Antengene Corporation has announced that the Indonesia National Agency of Drug and Food Control (BPOM) has approved a New Drug Application (NDA) for XPOVIO (selinexor) for three indications: (1) In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy;(2) in combination with dexamethasone for the treatment of adult patients with relapsed or refractory MM (R/R MM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors (PIs), at least two immunomodulatory agents (IMiDs), and an anti‐CD38 monoclonal antibody; and (3) as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B‐cell lymphoma (R/R DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy who are not eligible for haematopoietic cell transplant.
The ASEAN region, with its steady economic growth and a population exceeding 600 million, has become a market of significant potential for global biomedical development. The accelerating aging population in ASEAN has increased the overall disease burden on patients and local communities, leading to a growing demand for novel therapeutics. Currently, Antengene is actively expanding its presence into APAC markets in efforts to introduce more innovative medicines to the ASEAN region in the future, improving the level of healthcare in these regions and benefiting more patients in need.
While bringing XPOVIO to more APAC markets, Antengene is also striving to expand the indications of XPOVIO. Leveraging the drug's novel mechanism of action, Antengene is currently developing multiple combination regimens of XPOVIO for the treatment of various indications including myelofibrosis (MF) and endometrial cancer.
