Antengene has received approval from the Department of Health, the Government of the Hong Kong Special Administrative Region, for a new drug application for Xpovio (selinexor) along with dexamethasone (Xd) to treat relapsed and/or refractory multiple myeloma (R/R MM).
The treatment is indicated for use in adults who have received a minimum of four therapies previously, have a progression of the condition following the prior therapy and have disease refractory to a minimum of two immunomodulatory agents, an anti-CD38 monoclonal antibody and two proteasome inhibitors.
Xpovio is the first oral nuclear export protein inhibitor to receive approval in Hong Kong.
It is currently approved in 41 countries and regions, including Canada, Israel, the US, the UK, the European Union, Norway and Iceland.
Antengene Asia Pacific Region head and corporate vice-president Thomas Karalis stated: “Despite recent advances in the treatment of R/R MM, there remains an unmet need to extend survival for patients with this life-threatening disease and the approval of Xpovio presents Hong Kong patients with access to a novel therapy in their treatment of R/R MM.
“We will continue to build out Antengene’s presence across APAC markets and strive to expand the indications of Xpovio in Hong Kong and the broader APAC region, in efforts to bring renewed hope to more cancer patients.”