Antengene's Xpovio Bags Approval in Macau to Treat Multiple Myeloma

Antengene Corporation Limited (Antengene) announced that the Macau Pharmaceutical Administration Bureau has approved a New Drug Application (NDA) for Xpovio (selinexor) in combination with dexamethasone (Xd) for the treatment of adult patients with relapsed and/or refractory multiple myeloma (R/R MM) who have received at least four prior therapies and whose disease is refractory to at least two protea

Xpovio is the world's first oral selective inhibitor of the nuclear export protein XPO1, with regulatory approvals in 42 countries and regions including Mainland of China, Taiwan China, Hong Kong China, Macau China, South Korea, Singapore and Australia. In addition, multiple Xpovio regimens have been added to the clinical practice guidelines of major cancer societies in the US, the EU, and APAC, including the National Cancer Care Network (NCCN) Guidelines, the Chinese Society of Clinical Oncology (CSCO) Guidelines, the Guidelines for the Diagnosis and Management of Multiple Myeloma in China, as per pharmabiz.

"Antengene is excited to receive approval of Xpovio in Macau, first in the next wave of expected approvals in the APAC." said Dr. Jay Mei, Antengene's founder, chairman and CEO. "In recent years, the APAC region has witnessed a rapid growth in the population of patients with R/R MM, adding to the huge unmet clinical need of this patient population. I am glad that Xpovio has become the first and only XPO1 inhibitor approved for the treatment of patients with R/R MM in Macau China. To date, Xpovio has been approved in seven markets across APAC. While expanding the geographical presence of Xpovio, we are also striving to expand the indications of drug in the region in order to bring renewed hope to more patients and families."