Antengene has received approval from the Malaysian National Pharmaceutical Regulatory Agency for XPOVIO (selinexor) new drug application (NDA) for two indications to treat multiple myeloma (MM).
The approved indications for XPOVIO include its use along with bortezomib and dexamethasone for adults with MM who have undergone at least one prior therapy.
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It is additionally approved along with dexamethasone for adult patients with MM who have received at least four prior therapies and showed resistance to several other treatments, including two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody.
XPOVIO is a globally approved orally available XPO1 inhibitor.
The drug’s introduction in Malaysia will bring new therapeutic options to the clinical management of MM, offering benefits to numerous patients and their families.
It has previously been incorporated into national health insurance or reimbursement schemes in several Asia Pacific markets, including China, Australia, Singapore and South Korea.
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By GlobalDataAntengene has submitted NDAs for XPOVIO in Thailand and Indonesia, with approvals expected in the second half of 2024.
The company seeks to broaden its indications beyond the current approvals.
It is developing multiple combination regimens of XPOVIO to treat conditions such as myelofibrosis, T-cell non-Hodgkin’s lymphoma and endometrial cancer, leveraging the drug’s unique mechanism of action.
XPOVIO has synergistic effects when used in combination regimens, rapid onset of action and sustained responses.
Antengene is conducting multiple clinical studies of XPOVIO in China for the treatment of relapsed/refractory haematologic malignancies and solid tumours.
Three of these studies are a collaborative effort between Antengene and Karyopharm Therapeutics.
In July 2024 China’s National Medical Products Administration (NMPA) approved Antengene’s new indication of XPOVIO as a monotherapy for adults with relapsed or refractory diffuse large B-cell lymphoma.
