China’s National Medical Products Administration (NMPA) has approved a new indication of Antengene’s Xpovio (Selinexor) in diffuse large B-cell lymphoma (DLBCL).
Xpovio is now approved as a monotherapy to treat adult patients with relapsed or refractory (R/R) DLBCL.
The drug is an oral, selective inhibitor of XPO1, a nuclear export protein.
The latest development marks the second approved indication of Xpovio in China, followed by initial approval to treat relapsed/refractory multiple myeloma (R/R MM).
The new indication’s approval was supported by results from the registrational SEARCH study conducted in China on 60 patients with DLBCL.
Findings from this study revealed that participants treated in the trial met the pre-defined primary endpoint of overall response rate (ORR) based on central radiological review.
The study highlighted the clear efficacy of selinexor monotherapy administered orally in Chinese patients, showing notable response rates, sustained responses, and extended survival periods.
SEARCH study principal investigator and Peking University affiliated Beijing Cancer Hospital professor Jun Zhu said: “DLBCL is the most common subtype of NHL in adults and accounts for 40% of all NHL cases in China.
“The incidence of NHL has been steadily rising year over year, while patients with third- and later-lines relapsed or refractory disease lack effective and convenient therapies.
“As a nuclear export protein inhibitor with a novel mechanism of action (MOA), selinexor offers patients a new treatment option that is efficacious and easy to use, with oral availability that can reduce hospitalisation and financial burden on patients by allowing them to receive treatment at home.”
The drug has secured approvals in more than 40 countries and regions. It has also attained health insurance coverage in mainland China, Australia, Singapore, and South Korea.
Antengene has further submitted new drug applications (NDAs) in additional ASEAN markets such as Thailand, Malaysia, and Indonesia. The company is anticipating approvals in the second half of 2024.
The commercial-stage global biopharmaceutical company is presently advancing several combination regimens involving Xpovio for treating diverse indications such as myelofibrosis (MF), T-cell non-Hodgkin’s lymphoma (T-NHL), and endometrial cancer.
