XPOVIO® is the first and only exportin 1 (XPO1) inhibitor approved in Taiwan.
Antengene Corporation Limited, a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercialising first-in-class and/or best-in-class therapeutics in hematology and oncology, announced in October that the Taiwan Food and Drug Administration (TFDA) has approved a New Drug Application (NDA) for XPOVIO® (selinexor) for three indications:
- in combination with dexamethasone (Xd) for the treatment of adult patients with relapsed/refractory multiple myeloma (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; or
- in combination with bortezomib and dexamethasone (XVd) for the treatment of adult patients with MM who have received at least one prior therapy; and
- as a monotherapy for the treatment of adult patients with relapsed/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.
XPOVIO® is the world›s first oral selective inhibitor of the nuclear export protein XPO1, with regulatory approvals in 13 countries and regions including the United States, Israel, the United Kingdom, the European Union, Canada, Norway, Iceland, Lichtenstein, South Korea, Mainland China, Taiwan, Singapore and Australia.
To date, multiple XPOVIO® regimens have been added to the clinical guidelines of major oncology societies in the U.S., the EU, and APAC, including five regimens for the treatment of myeloma and one regimen for the treatment of lymphoma added to the guidelines of the National Cancer Care Network (NCCN); four regimens for the treatment of myeloma and one regimen for the treatment of lymphoma added to the guidelines of the Chinese Society of Clinical Oncology (CSCO); four regimens for the treatment of myeloma added to the Guidelines for the Diagnosis and Management of Multiple Myeloma in China; two regimens for the treatment of myeloma added to the guidelines of the European Society of Medical Oncology (ESMO); and one regimen for the treatment of myeloma added to the guidelines of the International Myeloma Working Group (IMWG).
“Antengene is very pleased to receive regulatory approval for XPOVIO® in Taiwan for R/R MM and R/R DLBCL. There remains an unmet need to extend survival for patients with these life-threatening diseases and XPOVIO® presents Taiwan physicians and patients with a new novel addition to existing therapies. We continue to build our Antengene presence across APAC markets and in Taiwan. We also look forward to introducing XPOVIO® and securing reimbursement in order to extend access to this first -in-class therapy for our physicians and patients,” said Thomas Karalis, Antengene’s Corporate Vice President, Head of Asia Pacific Region.
“XPOVIO® is approved in multiple markets in the APAC region. This novel product fulfils Antengene’s mission to bring first-in-class/best-in-class medicines to patients with cancer in APAC markets and beyond,” said Mr John Chin, Antengene’s Chief Business Officer. “Antengene is currently conducting eight clinical studies of XPOVIO® in mainland China for the treatment of patients with relapsed/refractory hematologic malignancies or solid tumo urs, and the drug’s safety and efficacy have already been validated in five registrational trials. Moving forward, we will strive to develop and commercialize more first-in-class and best-in-class drugs for patients with cancer or other life-threatening diseases.” [APBN]
Source: Antengene Corporation Limited