Xpovio is said to be the first authorised selective inhibitor of the XPO1 in the world that promotes the intranuclear accumulation and activation of tumour suppressor proteins and growth-regulating proteins
Antengene’s XPOVIO secures approval in Hong Kong. (Credit: Melany @ tuinfosalud.com on Unsplash)
Antengene announced that the Department of Health, the Government of the Hong Kong Special Administrative Region (HKSAR) has approved a New Drug Application (NDA) for the combination of Xpovio (selinexor) with dexamethasone (Xd) to treat adult patients with relapsed and/or refractory multiple myeloma (R/R MM).
HKSAR Department of Health has approved the combination for patients who were administered with a minimum of four therapies before and whose illness is refractory to at least two proteasome inhibitors (PIs), two immunomodulatory agents (IMiDs), an anti-CD38 monoclonal antibody, and who have shown disease progression on the last therapy.
Xpovio is said to be the first authorised orally-available, selective inhibitor of the nuclear export protein XPO1 in the world.
Antengene founder, chairman and CEO Jay Mei said: “I am pleased that Xpovio has become the first and only XPO1 inhibitor approved for the treatment of R/R MM in Hong Kong.
“The company’s Named Patient Program (NPP), a growing group of investigator-sponsored studies and ongoing advisory boards have helped us to ready the path for the successful adoption of Xpovio in Hong Kong.
“Moving forward, we will establish access to ASEAN markets that have a total population exceeding 600 million. To date, Antengene has successfully submitted NDAs in Macau China, Thailand, Malaysia and Indonesia.”
The Chinese pharmaceutical firm has secured regulatory approvals for Xpovio in 41 countries and regions.
As of now, six Xpovio regimens secure a total of 27 inclusions into seven clinical guidelines of oncology societies in the US, the EU, and APAC.
The multiple myeloma drug provides a new mechanism of action, synergistic effects along with regimens, fast onset of action, and durable responses.
It blocks the XPO1 and promotes the intranuclear accumulation and activation of tumour suppressor proteins and growth-regulating proteins. The drug also down-regulates the levels of multiple oncogenic proteins.