ANTENGENE-B(06996): The new drug market application of Xevor has been approved by the Indonesian Food and Drug Administration.
05/03/2025
GMT Eight
Antengene-B (06996) announces that the Indonesian Food and Drug Supervisory Agency (BPOM) has approved the new drug application (NDA) of Xevio (selinexor tablets) for three indications: (1) in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy; (2) in combination with dexamethasone for the treatment of adult patients with relapsed or refractory MM who have received at least four prior therapies and are refractory to at least two proteasome inhibitors (PIs), at least two immunomodulatory agents (IMiDs), and a monoclonal anti-CD38 antibody; and (3) as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (rrDLBCL) who have received at least two prior lines of systemic treatment and are ineligible for stem cell transplantation due to follicular lymphoma-induced DLBCL, unless otherwise specified.