The Malaysian National Pharmaceutical Regulatory Agency approved a supplemental new drug application (NDA) for selinexor (XPOVIO) in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after at least two lines of systemic therapy who are ineligible for autologous stem cell transplant, according to Antendene Corporation, the manufacturer of the therapy.
Selinexor is the first approved oral selective XPO1 inhibitor with a novel mechanism of action. It is approved in ten APAC countries and regions and included in national insurance coverage in five markets. This is the third indication for selinexor in Malaysia, following two approvals in multiple myeloma, according to a press release by Antengene.
