Malaysia Approves Antengene's XPOVIO for Multiple Myeloma

Antengene has secured approval from the Malaysian National Pharmaceutical Regulatory Agency for its new drug application (NDA) of XPOVIO (selinexor) aimed at treating multiple myeloma (MM). This approval covers two specific indications for the drug.

Firstly, XPOVIO has been approved for use in combination with bortezomib and dexamethasone in adult patients with MM who have undergone at least one prior therapy. Secondly, it is approved for use alongside dexamethasone in adult patients who have received at least four prior therapies and have shown resistance to various other treatments, including two proteasome inhibitors, two immunomodulatory agents, and an anti-CD38 monoclonal antibody.

XPOVIO is a globally recognized, orally available XPO1 inhibitor. The introduction of this drug in Malaysia is poised to offer new therapeutic options for managing MM, providing significant benefits to numerous patients and their families.

The drug's potential is highlighted by its prior inclusion in national health insurance or reimbursement schemes across several Asia Pacific markets. These markets include China, Australia, Singapore, and South Korea. Antengene has also submitted NDAs for XPOVIO in Thailand and Indonesia, anticipating approvals in the second half of 2024.

Beyond the current approvals, Antengene is aiming to expand the indications for XPOVIO. The company is developing multiple combination regimens for this drug to treat various conditions such as myelofibrosis, T-cell non-Hodgkin’s lymphoma, and endometrial cancer. These efforts leverage the unique mechanism of action that XPOVIO offers. The drug has demonstrated synergistic effects when used in combination regimens, showing rapid onset of action and sustained responses.

In China, Antengene is conducting several clinical studies on XPOVIO for the treatment of relapsed or refractory hematologic malignancies and solid tumors. Notably, three of these studies are part of a collaborative effort with Karyopharm Therapeutics.

In July 2024, China's National Medical Products Administration (NMPA) approved a new indication of XPOVIO as a monotherapy for adults with relapsed or refractory diffuse large B-cell lymphoma.