China-based biopharma Antengene Corp., Ltd (HKG: 6996) announced receiving marketing approval in Indonesia for its Xpovio (selinexor). The approval grants the drug three indications in the Southeast Asian country.
Indications Approved
The drug is approved for:
- Use in combination with bortezomib and dexamethasone for adult patients with multiple myeloma (MM) who have received at least one prior therapy.
- Use in combination with dexamethasone for adult patients with relapsed or refractory MM (R/R MM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors (PIs), at least two immunomodulatory agents (IMiDs), and an anti-CD38 monoclonal antibody.
- Use as a monotherapy for adult patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy who are not eligible for haematopoietic cell transplant.
Drug Background
Xpovio, the world’s first and only FDA-approved oral XPO1 inhibitor, was discovered by US-based Karyopharm Therapeutics Inc. (NASDAQ: KPTI). Antengene licensed the rights for the drug in Greater China, South Korea, and ASEAN countries in May 2018.
Global Presence
The drug is approved in mainland China, South Korea, Singapore, Malaysia, Australia, and other regions.-Fineline Info & Tech
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