China-based biopharma Antengene Corp., Ltd (HKG: 6996) has announced receiving market approval from the Taiwan Food and Drug Administration (TFDA) for its drug Xpovio (selinexor) in three indications. The approvals cover the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) and relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL).
Approved Indications
The TFDA has approved Xpovio for the following indications:
- In combination with dexamethasone for the treatment of adult patients with R/R MM who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody (mAb).
- In combination with bortezomib and dexamethasone to treat adults previously treated with one therapy for R/R MM.
- For the treatment of R/R DLBCL in adults who have received at least two prior lines of treatment.
Drug Background and Development
Discovered by US-based Karyopharm Therapeutics Inc. (NASDAQ: KPTI), Xpovio is the world’s first and only FDA-approved oral XPO1 inhibitor, used to treat hematological malignancies. Karyopharm licensed the rights for the drug to Antengene in Greater China, South Korea, and ASEAN countries in May 2018. The drug was first approved in the US to treat R/R MM and R/R DLBCL in 2019, and was conditionally approved in China in November 2021. It has since gained market approvals in Singapore and Australia in March 2023. Currently, eight clinical studies for the drug in hematological malignancies and solid tumors are ongoing in mainland China.
Future Outlook
The market approval in Taiwan further expands the reach of Xpovio, highlighting Antengene’s commitment to bringing innovative cancer treatments to patients in the region. This approval is expected to enhance the company’s market position and support its ongoing clinical development efforts.-Fineline Info & Tech
