Antengene’s new drug application (NDA) for Xpovio (selinexor) has gained approval from the Indonesia National Agency of Drug and Food Control for three indications.
The approval paves the way for Xpovio to be used in conjunction with other therapies and as a monotherapy in specific cancer treatments.
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The approval for the indications is in conjunction with bortezomib and dexamethasone for treating adults with multiple myeloma (MM) who have undergone a minimum of one previous treatment.
Xpovio can also be used as a single agent to treat adults with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL), including DLBCL which arises from follicular lymphoma, after a minimum of two systematic therapy lines.
Xpovio with dexamethasone is approved for treating adults with R/R MM who have undergone at least four previous therapies and whose disease is refractory to a minimum of two proteasome inhibitors (PIs), two immunomodulatory agents (IMiDs) and an anti‐cluster of differentiation 38 (CD38) monoclonal antibody.
With this new approval, the therapy extends its reach in the Asia Pacific (APAC) region, in which it has already been approved in 10 nations and included in national insurance schemes in five markets.
Antengene is currently working on broadening the therapy’s presence, aiming to introduce more medicines to the Association of Southeast Asian Nations (ASEAN) region.
The company is focused both on widening the market reach of Xpovio and on expanding its indications. It is exploring several combo regimens of the therapy for conditions including myelofibrosis and endometrial cancer.
Several clinical studies are underway in mainland China to evaluate Xpovio in treating relapsed/refractory haematologic malignancies and solid tumours.
Three of these are being conducted jointly by Antengene and Karyopharm Therapeutics.
In July 2024, China’s National Medical Products Administration approved Xpovio as a monotherapy for treating adults with R/R DLBCL.
