Antengene Gains Approval for XPOVIO® (selinexor) Commercialisation in Thailand
Tuesday, September 24, 2024
Antengene has announced that the Thailand Food and Drug Administration has approved a New Drug Application (NDA) for XPOVIO® (selinexor).
XPOVIO® is the first approved oral selective inhibitor of the nuclear export protein XPO1. It has a unique mechanism of action, providing synergistic benefits in combination therapies, with a rapid onset and sustained effects.
By inhibiting XPO1, XPOVIO® supports the accumulation of tumour suppressor proteins in the nucleus, reduces oncogenic protein levels, and restores hormone sensitivity through the glucocorticoid receptor pathway.
This approval covers two indications: the combination of XPOVIO® with bortezomib and dexamethasone for adult patients with multiple myeloma (MM) who have undergone at least one prior treatment, and the combination of XPOVIO® with dexamethasone for patients who have received at least four previous treatments and whose disease has become resistant to multiple therapies.
XPOVIO® is the first orally available selective XPO1 inhibitor, already approved in nine APAC markets. This latest approval in Thailand introduces a novel therapeutic option for MM patients, offering new hope to many in the country.
The drug has also been included in national health insurance or reimbursement schemes in China, Australia, Singapore, and South Korea.
The ASEAN region, with its growing population and increasing healthcare demands, represents an important market for biopharmaceutical innovation. Antengene recently secured approval for XPOVIO® in Malaysia and expects approval in Indonesia by the end of 2024. The company continues to focus on bringing innovative treatments to the ASEAN market, aiming to improve patient outcomes across the region.
In addition to expanding XPOVIO® into new markets, Antengene is working on broadening its use for additional indications, such as myelofibrosis and endometrial cancer. The drug’s mechanism of action includes promoting the accumulation of tumor suppressor proteins within the nucleus and reducing oncogenic protein levels.
Antengene is conducting multiple clinical studies in China to explore its use in treating relapsed and refractory hematologic cancers and solid tumors, in collaboration with Karyopharm Therapeutics.
Source: antengene.com
