Antengene has approved New Drug Application (NDA) for XPOVIO® (selinexor) in combination with dexamethasone for the treatment of relapsed and/or refractory multiple myeloma (R/R MM) patients who have received multiple prior therapies.
XPOVIO® stands as the world's pioneering orally-available, selective inhibitor of the nuclear export protein XPO1, with its approval marking a groundbreaking milestone.
Its novel mechanism of action introduces a fresh approach to treatment, complemented by the potential for synergistic effects within combination regimens. Notably, XPOVIO® exhibits rapid onset of action, contributing to its ability to yield prompt and enduring responses in patients.
XPOVIO® (selinexor) in combination with dexamethasone is designed for the treatment of adult patients with relapsed and/or refractory multiple myeloma (R/R MM) who have undergone at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors (PIs), two immunomodulatory agents (IMiDs), and an anti-CD38 monoclonal antibody, and who have shown disease progression on the last therapy.
Through its inhibition of the nuclear export protein XPO1, XPOVIO® prompts the accumulation and activation of tumour suppressor proteins and growth-regulating molecules within the cell nucleus. Furthermore, it leads to a reduction in the levels of various oncogenic proteins.